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 Sept. 30)
- Acceleron Pharma Inc XLRN
- Annexon Inc ANNX
- Arena Pharmaceuticals, Inc. ARNA
- Axonics Modulation Technologies Inc AXNX
- Beigene Ltd BGNE
- BioLife Solutions Inc BLFS
- Blueprint Medicines Corp BPMC
- Cardiff Oncology Inc CRDF
- CareDx Inc CDNA
- CTI BioPharma Corp CTIC
- I-Mab ADR IMAB
- Insulet Corporation PODD
- Kaleido Biosciences Inc KLDO
- Kura Oncology Inc KURA
- LifeSci Acquisition Corp LSAC (the blank check company announced a business combination with oncology-focused Vincera Pharma)
- Mirati Therapeutics Inc MRTX
- Momenta Pharmaceuticals, Inc. MNTA
- Myokardia Inc MYOK
- Novocure Ltd NVCR
- Pacific Biosciences of California Inc PACB
- PMV Pharmaceuticals Inc PMVP
- PPD Inc PPD
- Seattle Genetics, Inc. SGEN
- Shockwave Medical Inc SWAV
- Zoetis Inc ZTS
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows Sept. 30)
- Abeona Therapeutics Inc ABEO
- Alector Inc ALEC
- Jaguar Health Inc JAGX
- Lexicon Pharmaceuticals, Inc. LXRX
- Neos Therapeutics Inc NEOS
- Oncternal Therapeutics Inc ONCT
- Orchard Therapeutics PLC – ADR ORTX
- Pandion Therapeutics Inc PAND
- Satsuma Pharmaceuticals Inc STSA
- Theravance Biopharma Inc TBPH
- Tricida Inc TCDA
Stocks In Focus
Amag Reportedly Pursued By Apollo's Covis Pharma
AMAG Pharmaceuticals, Inc. AMAG shares surged higher after a Bloomberg report said Apollo Management's Covis Pharma unit is in advanced talks to buy Amag.
The stock was soaring 38.83% to $13.05 premarket Thursday.
FDA Finds Zosano Migraine Drug NDA Deficient
Zosano Pharma Corp ZSAN said it has received a discipline review letter from the FDA in connection with the Qtrypta NDA. A DRL is used by the FDA to convey preliminary comments on deficiencies identified during the review.
The DRL described two concerns with respect to the clinical pharmacology section of the NDA, the company said. Given the receipt of the letter, the company said the anticipated FDA decision may not come through by the Oct. 20 PDUFA date
The stock was down 52.48% at 77 cents premarket.
Selecta's Investigational Gout Treatment Flunks Midstage Study
Selecta Biosciences Inc SELB and licensing partner Swedish Orphan Biovitrum AB announced negative results for the Phase 2 COMPARE trial comparing the efficacy of SEL-212 to Horizon Therapeutics PLC's HZNP Krystexxa, the currently approved uricase in the U.S. for the treatment of chronic refractory gout.
"SEL-212 showed a numerically higher response rate on the primary endpoint during months 3 and 6 combined, but did not meet the primary endpoint of statistical superiority, Selecta said.
The stock was down 43.95% at $1.39 premarket.
See also: The Week Ahead In Biotech: FDA Decisions For Mesoblast And Eton, Coronavirus Vaccine Updates
Pfizer's Investigational DMD Gene Therapy Fast Tracked
Pfizer Inc. PFE announced fast track designation for its investigational gene therapy candidate, PF-06939926, which is being developed to treat Duchenne muscular dystrophy.
PF-06939926 is being evaluated to determine the safety and efficacy of this gene therapy in boys with DMD, Pfizer said.
The stock was gaining 0.71% to $36.96 in premarket trading Thursday.
Provention Bio Submits Type 1 Diabetes Drug's Clinical Module
Provention Bio Inc PRVB announced the submission of the clinical module of its BLA for teplizumab, codenamed PRV-031. Teplizumab is an investigational anti-CD3 monoclonal antibody that is being evaluated for the delay or prevention of clinical Type 1 diabetes in at-risk individuals.
The company said it plans to submit the final modules, including the chemistry, manufacturing and controls module, in the fourth quarter, which would mark the completion of the rolling BLA submission.
The stock was up 9.12% premarket at $14.
G1 Therapeutics Announces CEO Transition
G1 Therapeutics Inc GTHX said its CEO Mark Velleca will transition to the role of senior advisor and continue to serve as a member of the board effective Jan. 1.
The company also announced board member John Bailey as its next CEO.
The stock was up 2.51% premarket to $11.84.
Enlivex Reports Positive Results From COVID-19 Study
Enlivex Therapeutics Ltd ENLV announced positive top-line results of an investigator-initiated clinical trial of Allocetra in COVID-19 patients in severe/critical condition.
All five patients recovered completely from their respective severe/critical condition and were released from the hospital after an average of 5.5 days in severe patients and 8.5 days in critical patients following administration of Allocetra, at which time they were all COVID-19 PCR negative, the company said.
In premarket trading Thursday, the stock was rising 90.4% to $11.31.
Offerings
LogicBio Therapeutics Inc LOGC said it intends to offer shares of its common stock in an underwritten public offering. All shares being offered are to be sold by the company.
The company plans to use the net proceeds primarily for R&D, and the balance to fund working capital, capital expenditures and other general corporate purposes.
The stock was down 26.76% at $6.65 premarket.
Clinical Readouts
Capricor Therapeutics Inc CAPR is scheduled to present at the World Muscle Society congress with novel data from its Phase 2 HOPE-2 clinical trial with its lead investigational product, CAP-1002, in boys with Duchenne muscular dystrophy.
IPOs
Pulmonx Corporation, a commercial-stage medtech company that provides a minimally invasive treatment for patients with severe emphysema, a form of chronic obstructive pulmonary disease, priced its upsized 10-million-share initial public offering at $19 each compared to the estimated price range of $14-$16.
The Redwood City, California-based company expects to raise gross proceeds of $190 million from the offering. The shares are expected to be listed on the Nasdaq under the ticker symbol "LUNG."
Related Link: Attention Biotech Investors: Mark Your Calendar For October PDUFA Dates
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