The Daily Biotech Pulse: Biohaven, Bristol-Myers Squibb Snag FDA Approvals, Iterum UTI Drug Review On Track, Centessa Pharmaceuticals Debuts On Nasdaq - iShares Biotechnology ETF (NASDAQ:IBB)

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 May 27)

BioCryst Pharmaceuticals, Inc. BCRX (propped up by retail buying frenzy)
Celcuity Inc. CELC
I-Mab IMAB
PDS Biotechnology Corporation PDSB
PLx Pharma Inc. PLXP

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows May 27)

Biophytis SA BPTS
IMV Inc. IMV
Ionis Pharmaceuticals, Inc. IONS
Travere Therapeutics, Inc. TVTX
Valneva SE VALN

Stocks In Focus

Iterum Says FDA Regulatory Review Of Investigational Urinary Tract Infection Treatment On Track

Iterum Therapeutics plc ITRM announced that it participated in a late-cycle meeting with the FDA and said it responded to all issues raised by the agency regarding the new drug application for sulopenem etzadroxil/probenecid for the treatment of uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen.

The FDA has determined that an Advisory Committee meeting is not currently necessary. The review of the NDA is ongoing, and the FDA said it continues to work toward the PDUFA goal date of July 25.

The stock jumped 25.2% to $1.54 in after-hours trading.

Provention's Type 1 Diabetes Drug Wins Adcom Backing; Delay Likely In Approval Due To Previously Communicated Issues

Provention Bio, Inc. PRVB said the Endocrinologic and Metabolic Drugs Advisory Committee voted 10-7 in favor of the benefits of teplizumab outweighing the risks in support of approval to delay clinical type 1 diabetes mellitus. The PDUFA action date is July 2.

The previously disclosed matter surrounding pharmacokinetic comparability was not a topic for discussion during the Adcom meeting. The company reiterated its previous guidance that the FDA's PK comparability considerations are likely to result in a delay in potential biologic license approval timelines.

Biohaven's Migraine Drug Approved As Both Preventive, Treatment Option

Biohaven Pharmaceutical Holding Company Ltd. BHVN announced FDA approval of Nurtec ODT (rimegepant 75 mg) for the preventive treatment of migraine. It is indicated for adult patients with episodic migraine, e.g. those who experience less than 15 headache days per month.

The approved product label was also expanded to include the use of Nurtec ODT 75 mg up to 18 doses/month, allowing for both acute and preventive therapy in the same patient.

In after-hours trading, the stock rose 2.68% to $84.75.

Fennec Resubmits Regulatory Application For Drug to Treat Ototoxicity Induced By Chemotherapy In Kids, Adolescents

Fennec Pharmaceuticals Inc. FENC announced the resubmission of its NDA for Pedmark, a unique formulation of sodium thiosulfate, for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to less than 18 years of age with localized, non-metastatic, solid tumors.

The resubmission follows receipt of final minutes from a Type A meeting with the FDA.

The complete response letter issued by the FDA in August 2020 referred to deficiencies with the facility of the drug product manufacturer, while no clinical safety or efficacy issues were identified and there was no requirement for further clinical data.

Bristol-Myers Squibb's Zeposio Approved For Moderately to Severely Active Ulcerative Colitis

Bristol-Myers Squibb Co BMY announced FDA approval for Zeposia (ozanimod) 0.92 mg for the treatment of adults with moderately to severely active ulcerative colitis, a chronic inflammatory bowel disease.

"We're thrilled that our pursuit of transformative science in immunology may benefit patients in their ulcerative colitis treatment by introducing a new option that has a different mechanism of action than available therapies. Zeposia combines disease control through lasting remission and demonstrated safety in a once-daily pill," said Adam Lenkowsky, general manager and head, U.S., Cardiovascular, Immunology and Oncology, at Bristol-Myers Squibb.

Revolution Medicines Moves Lower On Insider Selling

Revolution Medicines, Inc. RVMD disclosed in a filing Third Rock Ventures II, which has a seat in the company's board, offloaded 1,366,204 shares of the company. After the transaction, TRV II owned 1,774,317 shares of the company.

The stock slipped 2.19% to $29.51 in after-hours trading.

Lucira Health Appoints MedTech Veteran Kevin Collins As Chief Revenue Officer

Lucira Health, Inc. LHDX announced the appointment of MedTech veteran Kevin Collins as chief revenue officer with global revenue responsibility.

The stock was down 3.19% to $4.86 in premarket trading Friday.

On The Radar

IPOs

Centessa Pharmaceuticals plc, a clinical-stage biopharma, announced that it has priced its initial public offering of 16.5 million ADSs, each representing one ordinary share, at $20 per ADS. All of the ADSs are being offered by Centessa.

The gross proceeds to Centessa from the offering are expected to be approximately $330 millionThe shares are expected to begin trading on the Nasdaq under the ticker symbol "CNTA."

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