Biotech Buzz: VIRX Cuts 23% Jobs, FDA Oks New Drug For Hypoparathyroidism, SIGA Down But Not Out

(RTTNews) - This week, once again, companies across the biotech sector continued to re-evaluate their pipelines and trim their workforces in a bid to conserve cash and extend their financial runway. Meanwhile, the regulatory landscape saw positive momentum with both new drug approvals and expanded indications. Against a backdrop of growing attention on monkeypox, Siga Technologies' Mpox vaccine candidate failed to impress in a clinical trial. Nevertheless, the company maintains a positive outlook regarding the treatment's future potential.

Let's dive into the details.

Layoffs

Viracta Therapeutics Inc. (VIRX), on Wednesday, announced that it is reducing its workforce by 23% as part of its pipeline reprioritization. The company has decided to pause the EBV+ solid tumor program and focus resources on the more advanced EBV+ lymphoma program. The lead drug candidate is Nana-val, which is under a phase II trial in patients with relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphoma, dubbed NAVAL-1. According to the company, data from the relapsed or refractory EBV-positive peripheral T-cell lymphoma (PTCL) cohort of the NAVAL-1 trial further highlights Nana-val's significant antitumor effectiveness and generally favorable safety profile.

VIRX closed Friday's trading at $0.30, down 11.76%.

Lykos Therapeutics, which failed to win FDA approval for its MDMA-assisted therapy for post-traumatic stress disorder (PTSD) early this month, on Thursday, announced it is laying off about 75% of its workforce. However, the company will continue its clinical research to address the FDA's questions regarding the rejected therapy.

Galera Therapeutics Inc. (GRTX), on Wednesday, announced that its Board of Directors has approved a Plan of Liquidation and Dissolution to wind down its business and operations. This plan will be presented for a vote at a special stockholders' meeting scheduled for around October 17, 2024. If the stockholders do not approve the plan, the company will continue to explore other strategic alternatives.

GRTX closed Friday's trading at $0.07, up 3.91%.

ACELYRIN INC. (SLRN), a late-stage clinical biopharma company, on Tuesday, revealed that as part of restructuring, its workforce will be reduced by approximately 40 people, or about 1/3 of its existing headcount. The company has decided to suspend new internal investment in the development of its investigational drug Izokibep in hidradenitis suppurativa, psoriatic arthritis and axial spondyloarthritis. Instead, it will focus its efforts primarily on advancing its other investigational drug, Lonigutamab, specifically for thyroid eye disease (TED). The phase I proof-of-concept portion of the ongoing Lonigutamab trial has been completed and the dose-ranging phase II portion in TED patients is continuing.

SLRN closed Friday's trading at $4.13, up 3.77%.

Lexicon Pharmaceuticals, Inc. (LXRX), on Tuesday, announced it is planning to reduce its headcount by more than 75, or approximately 50% of its current field force, by the end of the third quarter of 2024. The move comes following a strategic review of its commercial and pipeline programs, prompting the company to reallocate resources to areas where it believes it can have the most significant impact on patients. Consequently, the company will optimize its promotional efforts for INPEFA in heart failure and reallocate resources to support the potential commercial launch of ZYNQUISTA for improvement of glycemic control in adults with type 1 diabetes and chronic kidney disease. These changes are expected to reduce operating costs by $40 million.

LXRX closed Friday's trading at $1.66, up 1.22%.

Boundless Bio Inc. (BOLD), a clinical stage oncology company, on Monday, announced that it has decided to scale back its early discovery efforts, including a modest reduction in workforce, to extend its operating runway. However, the exact number or percentage of employees affected has not been disclosed. It was only as recently as March 28, 2024, the company's shares made their debut on the Nasdaq Global Select Market, priced at $16 per share. As of June 30, 2024, the company had cash, cash equivalents, and short-term investments of $179.3 million.

BOLD closed Friday's trading at $3.31, down 0.90%.

GRAIL Inc. (GRAL), a healthcare company, on Wednesday, announced that as part of restructuring, it is reducing existing headcount and planned hires for 2024 by approximately 30%. The cost reductions are expected to extend the company's existing cash runway from the second half of 2026 into 2028. The company completed the separation from Illumina (ILMN) on June 24, 2024.

GRAL closed Friday's trading at $16.75, up 5.55%.

Ovid Therapeutics Inc. (OVID), on Tuesday, announced that it is cutting down 17 positions, or 43% of its headcount, to prioritize its core programs and extend its cash runway. The company expects to incur $3.4 million of cash expenditures related to the restructuring. As part of pipeline prioritization process, the company is currently focusing resources on advancing OV888/GV101 and OV329 oral programs toward significant clinical milestones, while suspending the intravenous (IV) OV329 program and other preclinical programs. OV888/GV101 is under a phase II proof-of-concept study in cerebral cavernous malformations. OV329, being developed as a potential medicine for rare and treatment-resistant forms of epilepsy and seizures, is under phase I development.

OVID closed Friday's trading at $1.13.

FDA Approvals

AstraZeneca PLC's (AZN) blockbuster cancer drug Imfinzi, on Friday, received FDA approval for yet another use - this time, in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery in the treatment of resectable early-stage (IIA-IIIB) non-small cell lung cancer and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. In clinical trials, Imfinzi-based regimen reduced the risk of recurrence, progression or death by 32% vs. neoadjuvant chemotherapy alone in patients with resectable Stage IIA-IIIB non-small cell lung cancer, irrespective of PD-L1 expression. The drug is also approved for Small Cell Lung Cancer, Biliary Tract Tumor, Hepatocellular Carcinoma, and Endometrial Cancer. Imfinzi generated sales of $2,259 million in the first half of 2024, compared to $1,976 million in the year-ago period.

AZN closed Friday's trading at $84.41, down 0.58%.

Gilead Sciences Inc. (GILD), on Wednesday, announced that the FDA has granted accelerated approval for Livdelzi for the treatment of primary biliary cholangitis, a rare liver disease. The drug is indicated for use in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The use of Livdelzi is not recommended for people who have or develop decompensated cirrhosis. Livdelzi came under Gilead's fold following the acquisition of CymaBay Therapeutics for $4.3 billion in February of this year.

GILD closed Friday's trading at $73.78, down 0.75%.

The FDA, on Thursday, approved Incyte (INCY) and Syndax Pharmaceuticals' (SNDX) Niktimvo for the treatment of chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg. Niktimvo is Incyte's second approved treatment for chronic GVHD. The drug will be co-commercialized by Incyte and Syndax in the U.S. Incyte has exclusive commercialization rights for Niktimvo outside of the U.S. Niktimvo is expected to be launched in the U.S., no later than early first quarter 2025.

INCY closed Friday's trading at $62.16, up 0.78%.

Galderma, on Tuesday, received FDA approval for Nemluvio as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo nodularis, an underdiagnosed neuroimmune skin disease. Prurigo nodularis, characterized by several debilitating symptoms, including chronic itch, skin nodules covering large body areas, and poor sleep quality, is estimated to affect up to 181,000 people in the United States. The company has also sought FDA approval of Nemluvio for the treatment of moderate-to-severe atopic dermatitis, with a decision anticipated later this year.

Ascendis Pharma A/S (ASND), on Monday, secured FDA approval of Yorvipath for the treatment of hypoparathyroidism in adults. Hypoparathyroidism is a rare endocrine disease caused by insufficient levels of parathyroid hormone that impact multiple organs and affects an estimated 70,000 to 90,000 people in the United States. Yorvipath is the first and only treatment for this condition. The drug received approval in Europe last December.

ASND closed Friday's trading at $138.84, down 0.47%.

Deal or No Deal

Revance Therapeutics Inc. (RVNC), the maker of anti-wrinkle drug Daxxify, on Monday, agreed to be taken private by Crown Laboratories Inc, a skincare company, in a deal valued at $924 million or $6.66 per share in cash. The transaction is expected to be completed by the end of 2024. Revance is caught up in a trade secret conflict with Botox maker Allergan, a subsidiary of AbbVie Inc. (ABBV). Allergan has accused Revance of taking shortcuts by misappropriating trade secrets and repeatedly poaching multiple Allergan employees with access to those secrets.

RVNC closed Friday's trading at $6.62, up 0.46%.

AnaptysBio Inc. (ANAB), a clinical-stage biotechnology company, on Wednesday, priced an underwritten offering of 2.75 million shares of its common stock at a price of $36.50 each. The offering was led by long-standing investor EcoR1 Capital with participation from additional existing and new investors, including Sanofi (SNY). The gross proceeds from this offering are expected to be roughly $100 million. A phase IIb trial of the company's drug candidate ANB032 in atopic dermatitis is underway, with topline data expected in December.

ANAB closed Friday's trading at $34, up 4.78%.

Clinical Trials - Breakthroughs & Setbacks

Incyte (INCY), on Thursday, announced positive results from its pivotal phase III trial of Monjuvi in combination with lenalidomide and rituximab in patients with relapsed or refractory follicular lymphoma. In the study, dubbed MIND, the primary endpoint of progression free survival was met. The company plans to file a supplemental Biologics License Application for Monjuvi for the treatment of patients with follicular lymphoma who have failed at least one prior systemic anti-CD20 immunotherapy or chemo-immunotherapy by the end of the year. The drug is already approved by the FDA in combination with Lenalidomide for the treatment of relapsed or refractory Diffuse Large B-cell Lymphoma. Global sales of Monjuvi in the second quarter of 2024, were $31 million compared to $13 million in the year-earlier quarter.

INCY closed Friday's trading at $62.16, up 0.78%.

The National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases, on Thursday, released disappointing results from PALM 007 study in the treatment of Mpox. The trial evaluated patients in the Democratic Republic of the Congo with monkeypox (mpox), who were administered SIGA Technologies Inc.'s (SIGA) Tecovirimat, a highly targeted antiviral treatment, versus placebo. Preliminary analysis showed that the study did not reach statistical significance on its primary endpoint of Tecovirimat being superior to placebo in lesion resolution for all patients. However, a meaningful improvement was observed in patients receiving Tecovirimat whose symptoms began seven days or fewer before randomization and in those with severe or greater disease, defined by the World Health Organization (WHO) as having 100 or more skin lesions. Tecovirimat, is approved under brand name TPOXX, in the U.S. and Canada for the treatment of smallpox and authorized in Europe and the UK for the treatment of smallpox, mpox (monkeypox), cowpox, and vaccinia complications.

SIGA closed Friday's trading at $10.49, up 9.04%.

Pfizer Inc. (PFE) and BioNTech SE (BNTX), on Friday, announced mixed results from a phase III trial of their mRNA-based combination vaccine program against influenza and COVID-19 in individuals 18-64 years of age. While the combination vaccine candidate demonstrated a continued trend of higher influenza A responses compared to a licensed influenza vaccine, it showed lower geometric mean titers ("GMT") and seroconversion against the influenza B strain. The vaccine candidate also demonstrated comparable responses against SARS-CoV-2 when compared to the companies' licensed COVID-19 vaccine, Comirnaty.

PFE closed Friday's trading at $28.30, down 1.43%.