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. 19)
- Aldeyra Therapeutics Inc ALDX
- Athira Pharma Inc ATHA
- Bio-Rad Laboratories, Inc. Class B Common Stock BIO
- BioSpecifics Technologies Corp. BSTC - announced a deal to be bought by Endo International PLC ENDP for $658 million or $88.50 per share in cash
- Blueprint Medicines Corp BPMC
- CymaBay Therapeutics Inc CBAY
- Eidos Therapeutics Inc EIDX
- Forma Therapeutics Holdings Inc FMTX
- Immunomedics, Inc. IMMU
- Insmed Incorporated INSM
- Kymera Therapeutics Inc KYMR
- Larimar Therapeutics Inc LRMR
- Mirati Therapeutics Inc (NASDAQ: MRTX
- Nevro Corp NVRO
- Pacific Biosciences of California Inc PACB
- Shockwave Medical Inc SWAV
- Tarsus Pharmaceuticals Inc TARS (listed on Nasdaq Friday)
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows Oct. 19)
- Aerie Pharmaceuticals Inc AERI
- Corbus Pharmaceuticals Holdings Inc CRBP
- Cumberland Pharmaceuticals, Inc. CPIX
- Dyne Therapeutics Inc DYN
- Gilead Sciences, Inc. GILD
- Hoth Therapeutics Inc HOTH
- Intercept Pharmaceuticals Inc ICPT
- Oncternal Therapeutics Inc ONCT
- Opthea Limited OPT (listed on Nasdaq Friday)
- ProQR Therapeutics NV PRQR
- Titan Pharmaceuticals, Inc. common stock TTNP
Stocks In Focus
Aptinyx's NYX-783 Aces Midstage Study In Post-Traumatic Stress Disorder
Aptinyx Inc APTX announced positive results from the first Phase 2 study of its novel NMDA receptor modulator, NYX-783, in 153 patients with post-traumatic stress disorder.
In the Phase 2 study, NYX-783 demonstrated statistically significant and clinically meaningful efficacy results and a favorable adverse event and tolerability profile, the company said.
Based on these results, the company said it expects to initiate a pivotal study in 2021.
The stock was jumping 92.35% to $7.04 premarket Tuesday.
Cara Therapeutics Grants Vifor US License For Korsuva In Deal Valued Up To $440M
Cara Therapeutics Inc CARA and Vifor Pharma announced the signing of a license agreement for the commercialization of Korsuva injection for the treatment of chronic kidney disease associated with pruritus.
Cara provided Vifor with the commercial rights for IV Korsuva in the non-Fresenius Medical Care dialysis clinics, with the agreement giving Cara a 60% share of the profit and Vifor 40%.
Under the terms of the agreement, Cara will also receive an upfront payment of $100 million in cash and an equity investment of $50 million. In addition, Cara will be eligible to receive an additional equity investment upon U.S. regulatory approval of IV Korsuva, as well as milestone payments dependent on achieving commercial targets, which together could total up to $290 million.
In premarket trading Tuesday, Cara shares were jumping 16.65% to $16.25.
Centogene Raises FY20 Guidance Due On COVID-19 Testing, Recovery In Core Business
Centogene NV CNTG said it is increasing its full-year 2020 guidance from 60-65 million euros ($70.8 million to $75.6 million) to greater than 80 million euros.
The company attributed the positive expectation to further developments in its commercial COVID-19 testing and the continued recovery of its core business since the second quarter.
Separately, the company announced that CEO Arndt Rolfs is stepping down. Centogene is appointing Andrin Oswald as CEO effective Dec. 1.
The stock was adding 4.77% to $12.75 premarket Tuesday.
Related Link: The Week Ahead In Biotech: Spectrum Pharma FDA Decision, Biogen And Abbott Earnings, Cancer Conference
Merck Reports Positive Data For 2 Late-Stage Studies Of Pneumococcal Conjugate Vaccine
Merck & Co., Inc. MRK announced positive findings from two additional Phase 3 studies evaluating the safety, tolerability and immunogenicity of V114, its investigational 15-valent pneumococcal conjugate vaccine.
Merck shares were up 0.47% to $79.04 premarket Tuesday.
Cleveland BioLabs To Merge With Privately Held Cytocom In All-Stock Transaction
Cleveland BioLabs, Inc. CBLI announced a definitive merger agreement to combine its business with Cytocom in an all-stock transaction.
Cytocom shareholders will have a majority position in the newly combined entity. The shares will continue to be listed on the Nasdaq, and the initial board for the combined company will consist of four members selected by Cytocom and three members selected by Cleveland BioLabs. The boards of both companies have approved the combination.
In premarket trading Tuesday, Cleveland shares were up 68.66% to $3.66.
Inventiva Gets Fast Track Designation For Metabolic Disorder Drug
Inventiva ADR Representing Ord Shs IVA said the FDA has granted fast track designation to odiparcil, its clinical-stage drug candidate for the treatment of mucopolysaccharidoses type VI, a rare and progressive genetic disorder.
In premarket trading Tuesday, the stock was up 5.59% to $14.35.
Oric Pharma In-Licenses Genetic Cancer Drug
ORIC Pharmaceuticals Inc ORIC said it has entered into an exclusive license agreement with Voronoi to secure exclusive rights worldwide — excluding China, Hong Kong, Macau and Taiwan — for the development and commercialization of ORIC-114.
The drug is a brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target epidermal growth factor receptor and human epidermal growth factor receptor 2 with high potency against exon 20 insertion mutations.
ORIC said it expects to initiate a global Phase 1/2 tumor-agnostic trial in genetically defined cancers during the second half of 2021.
CytoDyn Says Data Monitoring Committee Recommends Continuation Of Registrational Late-Stage COVID-19 Study
CytoDyn Inc CYDY said that following a first interim analysis, the Data Safety Monitoring Committee that reviewed data from its Phase 2b/3 registrational trial of leronlimab in patients with severe-to-critical COVID-19 recommended that the trial continue without modification to achieve the primary endpoint.
The committee also requested another interim analysis when enrollment reaches the 75% level.
Offerings
BELLUS Health Inc BLU said it has entered into an underwriting agreement with a syndicate of underwriters comprising Jefferies, Evercore ISI and LifeSci Capital, relating to the public offering of 15.56 million common shares.
The shares are being sold at a public offering price of $2.25 per common share.
The stock was down 0.43% at $2.31 premarket Tuesday.
On The Radar
PDUFA Dates
Zosano Pharma Corp's ZSAN NDA for its migraine drug Qtrypta has a PDUFA action date of Oct. 20. With the company disclosing in late September that it has received a discipline review letter, which raised two concerns about the clinical pharmacology section of the NDA, a decision Tuesday seems unlikely.
Related Link: Attention Biotech Investors: Mark Your Calendar For October PDUFA Dates
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