First Generic Version Of NuvaRing Gets FDA Nod, ONCT On Watch, SRPT Surges

(RTTNews) - Today's Daily Dose brings you news about the sweet surprise for Sarepta; spike in Amneal Pharma's stock price; Oncternal Therapeutics' breast cancer trial results and Centene's 2020 outlook.

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Amneal Pharmaceuticals Inc.'s (AMRX) Abbreviated New Drug Application for EluRyng has been granted approval by the FDA. EluRyng is the first generic version of NuvaRing, a flexible vaginal ring used to prevent pregnancy.

Amneal has initiated commercialization activities for EluRyng. According to IQVIA, a healthcare data and analytics provider, NuvaRing U.S. annual sales for the 12 months ended October 31, 2019, were approximately $976 million.

EluRyng is one of 15 new, complex products that the Company expects to launch over the next 18 to 24 months.

AMRX closed Thursday's trading at $5.04, up 44.83%.

Assertio Therapeutics Inc. (ASRT) has sold Gralise, a prescription medicine used to treat pain after shingles, or postherpetic neuralgia, to privately-held Alvogen, for $127.5 million.

As per the agreement that is expected to close in early January 2020, Alvogen will acquire and assume all responsibilities associated with the product Gralise.

Commenting on the deal, Arthur Higgins, President and Chief Executive Officer of Assertio, said, "This transaction continues the transformation of Assertio, allows us to focus on our growth products, CAMBIA and Zipsor, strengthens our balance sheet, and increases our flexibility for future business development opportunities."

ASRT closed Thursday's trading at $1.23, up 56.65%.

Centene Corp (CNC) is optimistic that it will continue to deliver on its growth strategy with strong top and bottom-line performance in fiscal 2020.

The Company expects total revenues to be in the range of approximately $78.6 billion to $79.4 billion, and adjusted earnings per share of about $4.64 to $4.84. Analysts polled by Thomson Reuters expect the Company to report revenue of $79.92 billion and earnings of $4.84 per share.

The 2020 guidance excludes Centene's pending WellCare acquisition, associated one-time integration costs, the related financing and closing costs, and the impact of the previously announced divestitures. The acquisition is subject to regulatory approval and is expected to close in the first half of 2020.

CNC closed Thursday's trading at $58.52, down 0.20%.

Oncternal Therapeutics Inc. (ONCT) has announced encouraging interim data from the ongoing, investigator-sponsored phase Ib clinical study of Cirmtuzumab in combination with paclitaxel in patients with HER2-negative, metastatic or locally-advanced unresectable breast cancer.

The study involved a total of eight patients with HER2-negative, metastatic or locally-advanced unresectable breast cancer, and seven of the eight patients were evaluable for safety and efficacy.

The treatment with Cirmtuzumab in combination with paclitaxel has resulted in four of the seven evaluable patients achieving a partial response, for an objective response rate of 57%, including one partial response that continued on Cirmtuzumab alone for 30 weeks after discontinuing paclitaxel, the Company noted.

The combination of Cirmtuzumab and paclitaxel has been well tolerated in the trial, with no study discontinuations for toxicity and no dose-limiting toxicities observed to date, added the Company.

ONCT closed Thursday's trading at $4.60, up 0.22%. In after-hours, the stock was up 1.74% to $4.68.

The FDA has approved Pfizer Inc.'s (PFE) XELJANZ(r) XR extended-release 11 mg and 22 mg tablets for the once-daily treatment of adult patients with moderately to severely active ulcerative colitis, after an inadequate response or intolerance to TNF blockers.

Xeljanz 10 mg twice-daily (BID) for at least eight weeks, followed by Xeljanz 5 mg BID or 10 mg BID, was approved by the FDA LAST May for the treatment of adult patients in the U.S. with moderately to severely active ulcerative colitis.

The drug brought home sales of $1.77 billion in full-year 2018 and $1.63 billion in the first nine months of 2019 for Pfizer.

Xeljanz is also indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis and active psoriatic arthritis.

PFE closed Thursday's trading at $38.54, up 0.84%.

Almost four months after denying approval for Sarepta Therapeutics Inc.'s (SRPT) Duchenne muscular dystrophy therapy Vyondys 53 over safety concerns, the FDA, in a surprise move has reversed its decision.

VYONDYS 53, on Thursday, was granted accelerated approval by the FDA, and it becomes Sarepta's second RNA exon-skipping treatment for DMD to be approved in the U.S.

VYONDYS 53 is a phosphordiamidate morpholino oligomer developed for the treatment of patients with Duchenne muscular dystrophy who have genetic mutations subject to skipping exon 53 of the dystrophin gene. Patients with a 53 mutation represent 8 percent of those with Duchenne.

The Company already has one approved drug for Duchenne muscular dystrophy, by the name Exondys 51 that is used to treat those with DMD caused by a mutation amenable to skipping exon 51, which affects about 13 percent of the population with DMD.

VYONDYS 53 is priced at parity to EXONDYS 51, noted the Company. The cost of EXONDYS 51 exceeds $1 million a year.

SRPT closed Thursday's trading at $100.47, down 0.97%. In after-hours, the stock rose 29.45% to $130.06.