Here's a roundup of top developments in the biotech space over the last 24 hours.
Stocks In Focus
Karyopharm Says FDA Mandates Additional Study For Expanding Selinexor Label To Include Advanced Endometrial Cancer
Karyopharm Therapeutics, Inc. KPTI said following discussions with the U.S. Food and Drug Administration regarding its previously planned supplemental new drug Application for selinexor in advanced or recurrent endometrial cancer, the regulator conveyed that topline results from the Phase 3 SIENDO study are unlikely to support approval.
The regulator said further exploration of patients with advanced or recurrent endometrial cancer with p53 wild-type is warranted. Taking into account, the FDA's feedback, the company intends to initiate a new study of selinexor in patients with p53 wild-type endometrial cancer and believes top-line data will be available in the first half of 2024.
The stock was slumping 26.95% to $7.59 in premarket trading.
Finch Pauses Phase 3 Study Of Microbiome Therapeutic CP101 Following FDA's Clinical Hold
Finch Therapeutics Group, Inc. FNCH announced that it has paused enrollment in PRISM4 Phase 3 clinical trial of CP101 in recurrent C. difficile infection following the receipt of a clinical hold letter from FDA on Feb. 24, requesting additional information about Finch's SARS-CoV-2 donor screening protocols.
The company said it expects to expeditiously provide the requested information and intends to work closely with the FDA to resolve the clinical hold as soon as possible. It also stated that it is evaluating any potential impact the clinical hold may have on the timing of the expected readout of topline data the study.
In premarket trading, the stock was pulling back 13.81% to $7.24.
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Celyad Phase 1b Colorectal Cancer Study Placed On Hold
Celyad Oncology SA CYAD announced that FDA sent an email on March 1 that its CYAD-101-002 Phase 1b trial has been placed on clinical hold due to insufficient information to assess risk to study subjects. The company had earlier on Feb. 28, announced it's voluntarily pausing the CYAD-101-002 trial to investigate reports of two fatalities in the study.
SAB Biotherapeutics Says NIH Stops Phase 3 Trial Of COVID-19 Treatment Candidate
SAB Biotherapeutics SABS reported that due to low hospitalization and death rates in the trial, the National Institutes of Health's ACTIV-2 Program is discontinuing enrollment in its Phase 3 trial evaluating SAB-185 in COVID-19.
Adagene Announces R&D Collaboration With Sanofi For Masked Versions Of Antibodies
Adagene Inc. ADAG announced a collaboration and exclusive license agreement with Sanofi SNY to generate masked monoclonal and bispecific antibodies for development and commercialization by Sanofi.
Under the terms of the agreement, Adagene will be responsible for early-stage research activities to develop masked versions of Sanofi candidate antibodies, using Adagene's SAFEbody technology. Sanofi will be solely responsible for later stage research and all clinical, product development and commercialization activities.
Sanofi will make an upfront payment of $17.5 million to Adagene and will have the ability to advance two initial Sanofi antibody candidates in the collaboration, followed by an option for two additional candidates. Adagene will also be eligible to receive total potential development, regulatory and commercial milestone payments of up to $2.5 billion and tiered royalties on global net sales of approved collaboration products.
Pfizer's RSV Vaccine Candidate For Infants Gets Breakthrough Designation
Pfizer, Inc. PFE said its respiratory syncytial virus vaccine candidate, PF-06482077 or RSVpreF, received breakthrough therapy designation from the FDA for the prevention of RSV-associated lower respiratory tract illness in infants from birth up to six months of age by active immunization of pregnant women.
CytomX Therapeutics, Inc.'s CTMX fourth-quarter revenues rose from $16.4 million in 2020 to $19.7 million in 2021, in line with the consensus estimate.
The stock was gaining 10.17% to $3.9 in premarket trading.
REGENXBIO Inc. RGNX reported fourth-quarter revenues of $398.7 million in 2021, up from $21.4 million in 2020. The company reversed to a profit of $6.67 per share from a loss of $1.24 per share. Analysts, on average, estimated a profit of $4.71 per share.
In premarket trading, the stock was up 9.64% to $29.
ChemoCentryx, Inc. CCXI reported revenues of $965,000 for the fourth quarter of 2021, missing the consensus estimate of $4.22 million. The net loss per share widened from 43 cents to 58 cents.
The stock was slipping 12.76% to $25.70 in premarket trading.
Inovio Pharmaceuticals, Inc. INO reported fourth-quarter revenues of $1.8 million, down from $5.6 million a year ago. The net loss per share narrowed from $1.45 to 50 cents but it was wider than the consensus estimate for a loss of 32 cents per share.
The stock was moving down 10.49% to $2.90 in premarket trading.
Kodiak Sciences, Inc. KOD reported a wider loss of $1.79 per share, down from 97 cents per share last year. Analysts, on average, had expected a loss of $1.36 per share.
The stock was retreating 8.48% to $8.09 in after-hours trading.
Hookipa Pharma, Inc. HOOK said it intends to sell shares of its common stock and shares of its non-voting Series A convertible preferred stock in an underwritten public offering. All of the securities in the Offering are to be sold by HOOKIPA.
The stock was retreating 15.08% to $1.14 in premarket trading.
On The Radar
Amneal Pharmaceuticals, Inc. AMRX (before the market open)
Jounce Therapeutics, Inc. JNCE
Intercept Pharmaceuticals, Inc. ICPT
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