Here's a roundup of top developments in the biotech space over the last 24 hours:
Scaling The Peaks
(Biotech Stocks Hitting 52-week Highs July 19)
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows July 19)
Stocks In Focus
FDA Identifies Deficiencies In Ardelyx's NDA For Drug To Treat Elevated Blood Phosphorous Levels
The notification does not reflect a final decision on the information under review. The company immediately requested a meeting to discuss the deficiencies and was notified by the FDA Monday that the request for a meeting was denied.
"While the FDA has not provided specific details regarding the deficiencies, the FDA noted that a key issue is the size of the treatment effect and its clinical relevance," Ardelyx said.
Tenapanor's PDUFA goal date was fixed for July 29.
The stock was plunging 73.25% to $2.06 premarket Tuesday.
Myovant Receives European Commission Approval For Uterine Fibroid Treatment
Myovant Sciences (NYSE:MYOV) announced the European Commission has approved the marketing authorization application for Ryeqo for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age, with no limitation for duration of use.
The EC decision is valid in all 27 member states of the European Union, as well as Iceland, Norway and Liechtenstein.
Immunome Says COVID-19 Antibody Cocktail Effective Against Delta Variant In Animal Study
The stock was jumping 25% to $20.80 in premarket trading.
PLx Pharm's Liquid-Filled Aspirin Capsule To Land On Walgreens Shelves In August
Three stock-keeping units of Vazalore, PLx Pharma Inc.'s (NASDAQ:PLXP) first and only FDA-approved liquid-filled aspirin capsules, will be available in over 8,000 Walgreens Boots Alliance, Inc. (NYSE:WBA) stores nationwide later in August.
In premarket trading, the stock was adding 9.36% to $18.57.
Merck Announces Positive Phase 2a Data For Islatravir As Pre-Exposure HIV Prophylaxis
After 24 weeks, once-monthly oral islatravir was generally well tolerated versus placebo. The levels of islatravir in peripheral blood mononuclear cells (PBMCs) also remained above the pre-specified efficacy PK threshold for PrEP at both doses studied, eight weeks after the last study dose.
The stock was up 0.16% at $77.17 in premarket trading.
Related Link: The Week Ahead In Biotech: Earnings Kickstart With J&J And Biogen, Albireo Awaits FDA Decisions, More IPOs
Amneal Lands FDA Approval For Generic Version of Eye Inflammation Treatment
Amneal Pharmaceuticals, Inc. (NYSE:AMRX) announced that it has received abbreviated NDA approval from the FDA for the generic version of TobraDex, which adds another complex ophthalmic product to the generics portfolio.
Dexamethasone and Tobramycin Ophthalmic Suspension 0.3%/0.1% is the generic version of TobraDex, which is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.
The stock was seen moving up 4.4% to $4.51 in premarket trading.
Lantern Announces Positive Preclinical Data For Pancreatic Cancer Drug
Lantern Pharma (NASDAQ:LTRN) announced positive new data from its ongoing pancreatic cancer collaboration with the Pancreatic Cancer Institute at Fox Chase Cancer Center.
Preclinical data demonstrated that the drug candidate, LP-184, demonstrated significant and rapid pancreatic tumor shrinkage, by over 90%, in in-vivo mouse models in eight weeks, the company said. In comparison, the tumors in the untreated mice grew by over eleven-fold in volume during the same eight-week period, it added.
The stock was rallying 20.08% to $15.30 in premarket trading.
Integra LifeSciences Announces Positive Data For Diabetic Foot Ulcer Treatment
AnPac Bio-Medical Preannounces Strong Testing Volume Growth For Q2
AnPac Bio-Medical Science (NASDAQ:ANPC) pre-announced Tuesday that it has experienced strong growth in test volume in the first half year of 2021, with total number of paid customers and testing volume increasing almost 110% compared with the same period in 2020.
In addition, in the second quarter, the total paid tests and paid cancer tests increased approximately 280% and approximately 270%, respectively, quarter-over-quarter. Other tests including new test products launched in 2020 have also grown, the company said.
In premarket trading, the stock was up 9.23% at $4.38.
Offerings
Brickell Biotech, Inc. (NASDAQ:BBI) said it has entered into an underwriting agreement with H.C. Wainwright & Co. under which the underwriter has agreed to purchase on a firm commitment basis 8.065 million shares of common stock of the company at a price to the public of 62 cents per share, less underwriting discounts and commissions.
The closing of the public offering is expected to occur on or about July 22.
The stock was down 2,085% at 58.31 cents in premarket trading.
CytoKinetics said, subject to market and other conditions, it plans to offer $200 million in shares of its common stock in an underwritten public offering. All of the shares of common stock in the offering will be sold by Cytokinetics.
In premarket trading, the stock was up 2.33% at $27.63.
On The Radar
PDUFA Dates
The FDA is expected to rule on Albireo Pharma, Inc.'s (NASDAQ:ALBO) new drug application for odevixibat for the treatment of pruritus in patients with progressive familial intrahepatic cholestasis, a rare inherited progressive liver disease.
Bylvay has been approved as the brand name for odevixibat.
Earnings
Intuitive Surgical, Inc. (NASDAQ:ISRG) (after the close)
IPOs
Related Link: Attention Biotech Investors: Mark Your Calendar For July PDUFA Dates
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