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 Oct. 15)
- Amicus Therapeutics, Inc. FOLD
- Beam Therapeutics Inc BEAM
- Bio-Rad Laboratories, Inc. Class B Common Stock BIO
- Kronos Bio Inc KRON (IPOed Friday)
- Larimar Therapeutics Inc LRMR
- Pacific Biosciences of California Inc PACB
- Rocket Pharmaceuticals Inc RCKT
- Twist Bioscience Corp TWST
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows Oct. 15)
- ADC Therapeutics SA ADCT
- Alector Inc ALEC
- Artelo Biosciences Inc ARTL
- Aziyo Biologics Inc AZYO
- Codiak BioSciences Inc CDAK (listed on Nasdaq Wednesday)
- Cumberland Pharmaceuticals, Inc. CPIX
- Dyne Therapeutics Inc DYN
- Pandion Therapeutics Inc PAND
- ProQR Therapeutics NV PRQR
- Silence Therapeutics ADR Representing 3 Ord Shs SLN
- Titan Pharmaceuticals, Inc. common stock TTNP (provided a strategic and corporate update)
- Uniqure NV QURE
Stocks In Focus
Zogenix Presents Data Showing Durability of Response For Seizure Drug
Zogenix, Inc. ZGNX released interim data from open-label extension trial, showing substantial seizure reductions were maintained when treated with Fintepla oral solution for up to two years. Post-hoc analysis showed number needed to treat to achieve a clinically meaningful response compared favorably to similar studies of other Dravet syndrome therapies, the company added.
Fintepla was approved by the FDA for the treatment of seizures associated with Dravet syndrome in June.
The data was presented at the Child Neurology Society and International Child Neurology Congress.
The stock rose 7.03% to $21 in after-hours trading.
Amarin Presents Positive Post-hoc Analyses of Vascepa Data
Amarin Corporation plc AMRN presented at the Transcatheter Cardiovascular Therapeutics Connect 2020 post hoc subgroup analyses of REDUCE-IT study, showing Vascepa compared with placebo, significantly reduced primary composite first and total major adverse cardiovascular events, or MACE, in patients with a history of percutaneous coronary intervention by 34% and 39%, respectively.
Vascepa reduced key secondary composite first hard MACE, comprised of heart attacks, stroke and cardiovascular death, by 34%, it added.
In after-hours trading, the stock added 3.96% to $5.25.
Chembio Submits EUA Application For Rapid COVID Antigen Test
Chembio Diagnostics Inc CEMI announced the submission of an application for emergency use authorization to the FDA for the DPP SARS-CoV-2 Antigen test system, which has been designed to detect SARS-CoV-2 antigens in only 20 minutes.
The stock gained 3.53% to $4.99 in after-hours trading.
Orchard Gets European Medicines Agency Committee's Recommendation For Rare Inherited Disease
Orchard Therapeutics PLC – ADR ORTX said the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending full, or standard, marketing authorization for Libmeldy, an investigational gene therapy for the treatment of metachromatic leukodystrophy, characterized by biallelic mutations in the ARSA gene.
A final decision by the EC for Libmeldy is anticipated before the end of 2020, the company said.
In premarket trading Friday, the stock was up 7.14% to $4.50.
Galapagos' Osteoarthritis Drug Fails to Meet Primary, Secondary Endpoints In a Phase 2 Study
Galapagos ADR Representing Ord Shs GLPG and Servier announced topline results from their ROCCELLA Phase 2 study of GLPG1972/S201086 in osteoarthritis patients, showing no signal of activity was observed.
The study participants were treated with three different once-daily oral doses of the combo over 52 weeks of treatment period. The primary objective of the study was to show efficacy of in reducing cartilage loss of the central medial tibiofemoral compartment of the target knee via quantitative MRI.
Galapagos shares were slipping 8.48% to $126.75 in premarket trading.
Intersect ENT Expects Q3 Revenues to Exceed Expectation
Intersect ENT Inc XENT announced preliminary third-quarter revenues of $22.4 million to $22.8 million, ahead of the $21.37-million consensus estimate. As of Sept. 30, cash and marketable securities stood at $130 million.
"Our solid third quarter preliminary revenue reflects a continuation of increased sequential sinus surgery procedure demand leading to strong volumes of PROPEL, with notable year-on-year growth of PROPEL in the office setting," the company said.
Based on current trends, the company projected fourth-quarter revenues to be 85-90% of the year-ago revenues, while analyst estimate revenues to be about 95% of 2019 fourth-quarter levels.
Offerings
Rocket Pharmaceuticals announced the secondary offering of 17.34 million shares of its Class A ordinary shares by selling shareholders in an underwritten public offering has been priced at $42 apiece.
The offering is expected to close Oct. 20.
On The Radar
Clinical Readouts
Rocket Pharma is scheduled to present at the European Society for Immunodeficiencies 2020 meeting an update on data from the Phase 1 portion of the Phase 1/2 clinical trial of RP-L201, lentiviral-mediated ex-vivo gene therapy, for leukocyte adhesion deficiency-I. The company will also present an e-poster consisting of preclinical study data on RP-L401 for infantile malignant osteopetrosis.
IPOs
Irvine, California-based Tarsus Pharmaceuticals, Inc., which is focused on developing therapies primarily for ophthalmic conditions, priced its upsized initial public offering, or IPO, of 5.5 million shares at $16 for raising gross proceeds of $88 million. The company had earlier estimated a price range of $15-$17. The shares are expected to begin trading on the Nasdaq under the ticker symbol TARS.
Aligos Therapeutics, Inc., a South San Francisco, California-based clinical-stage biopharma currently focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, priced its IPO of 10 million shares at $15 per share, which is at the mid-point of the estimated price range of $14-$16. The company expects to raise gross proceeds of $150 million from the offering. The shares will likely begin trading on the Nasdaq under the ticker symbol ALGS.
Houston, Texas-based Kiromic biopharma, Inc. priced its upsized IPO of 1.25 million shares at $12 apiece, which is the lower bound of the estimated price range of $12-$14. Gross proceeds from the offering is estimated at $15 million. The immuno-oncology company said its shares will begin trading on the Nasdaq under the ticker symbol KRPB.
Cambridge in Massachusetts-based Praxis Precision Medicines Inc. priced its upsized IPO of 10 million shares at $19, above the estimated price range of $16-$18. The company, which translates genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance, expects the shares to be listed on the Nasdaq under the ticker symbol PRAX. Gross proceeds from the offering are expected at $190 million.
Related Link: Attention Biotech Investors: Mark Your Calendar For October PDUFA Dates
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