The following is a roundup of top developments in the biotech space over the last 24 hours:
Scaling The Peaks
(Biotech stocks that hit 52-week highs Nov. 7.)
- Collegium Pharmaceutical Inc COLL (reacted to third-quarter results released after the market close Wednesday)
- Deciphera Pharmaceuticals Inc DCPH
- DexCom, Inc. DXCM (reacted to its better-than-expected third-quarter results)
- INNATE PHARMA S/S ADR IPHA
- Rapt Therapeutics Inc RAPT (went public Oct. 31)
- Viela Bio Inc VIE (went public Oct. 3)
- XOMA Corp XOMA
Down In The Dumps
(Biotech stocks that hit 52-week lows Nov. 7.)
- Allena Pharmaceuticals Inc ALNA (reported positive results from two studies evaluating its reloxaliase in high-risk patients with enteric hyperoxaluria and advanced chronic kidney disease)
- Auris Medical Holding Ltd EARS
- bluebird bio Inc BLUE
- Caladrius Biosciences Inc CLBS (reacted to its third-quarter results)
- CENTOGENE ORD CNTG (went public Thursday)
- Cocrystal Pharma Inc COCP
- Corbus Pharmaceuticals Holdings Inc CRBP
- Helius Medical Technologies Inc HSDT
- Infinity Pharmaceuticals Inc. INFI
- Iterum Therapeutics PLC ITRM
- Midatech Pharma PLC-ADR MTP
- Mirum Pharmaceuticals Inc MIRM (reacted to third-quarter results)
- MOTIF BIO PLC/S ADR MTFB
- Neuronetics Inc STIM
- Obseva SA OBSV (flunked a late-stage study of nolasiban in women undergoing embryo transfer following in-vitro fertilization)
- Ocugen Inc OCGN
- Onconova Therapeutics Inc ONTX
- Oyster Point Pharma Inc OYST (went public Oct. 31)
- Pluristem Therapeutics Inc. PSTI
- Salarius Pharmaceuticals Inc SLRX
- Seelos Therapeutics Inc SEEL
- Neuralstem, Inc. SNCA
- Sensus Healthcare Inc SRTS
- Sierra Oncology Inc SRRA (announced common stock offering)
- Tonix Pharmaceuticals Holding Corp TNXP
Stocks In Focus
Affimed Exercises Final Option With Genentech For Immunotherapy Target
Affimed NV AFMD said Genetech, a unit of Roche Holdings AG Basel ADR RHHBY, has exercised its final option for an exclusive target under the collaboration agreement to develop and commercialize NK cell engager-based immunotherapies generated from Affimed's ROCK platform to treat multiple cancers.
Following this, Affimed is to receive a milestone payment of an undisclosed size, the company said.
Separately, the company said it has commenced an underwritten common stock offering. The company also said it has received FDA clearance for its IND to commence human Phase 1/2a trial of AFM24 in EGFR-expressing cancers. The company expects to start the trial in the first half of 2020.
Affimed shares were down 9.69% at $2.61 in Friday's premarket session.
Alimera Announces 1-for-15 Reverse Stock Split
Alimera Sciences Inc ALIM announced board approval for a 1-for-15 reverse stock split, which will become effective after the close of trading Nov. 14. The stock will begin trading on a reverse split-adjusted basis on Nov. 15.
The stock was down 23.5% at 21 cents in Friday's premarket session.
Therapix, Destiny Biosciences End Merger Talks
Therapix Biosciences Ltd – ADR TRPX, a biotech focusing on cannabinoid-based treatment, announced the discontinuation of negotiations on a previously announced proposed merger with Destiny Biosciences Global Corp.
"Having discontinued our negotiations with Destiny, Therapix is considering other options to achieve the benefits of a merger, which includes exploring other strategic offers we've received and continuing to develop our unique technologies," interim Therapix CEO Ascher Shmulewitz said in a statement.
The stock was down 18.03% at $2 in the premarket session.
Fibrogen's Anemia Drug Meets Primary Efficacy Endpoints
FibroGen Inc FGEN announced results from the Phase 3 study dubbed HIMALAYAS, which is evaluating roxadustat for the treatment of anemia in incident dialysis patients with chronic kidney disease. The study met both primary efficacy endpoints. Roxadustat showed non-inferiority to epoetin alfa.
Roxadustat is co-developed by FibroGen, AstraZeneca plc AZN and ASTELLAS PHARMA/ADR ALPMY.
FibroGen shares were down 1.24% at $37.50 at the time of publication.
Adamas Pharmaceuticals Inc ADMS reported third-quarter revenue of $13.93 million, higher than the $10.61 million reported last year. The net loss narrowed from $1.22 per share to 99 cents per share, while analysts estimated a narrower loss of 89 cents per share.
The stock was down 10.64% at $4.20.
Stemline Therapeutics Inc STML reported net product revenue of $13.33 million versus zero revenue one year ago. The company's net loss per share narrowed from 73 cents to 34 cents.
Analysts estimated a loss of 45 cents per share on revenue of $13.64 million.
The stock fell 10.92% to $9.30.
NovaBay Pharmaceuticals, Inc. NBY's third-quarter net sales fell from $3.1 million in 2018 to $1.6 million in 2019. The net loss for the quarter narrowed from 9 cents per share to a penny per share.
The stock was down 12.58% at 66 cents at the time of publication.
Viveve Medical Inc VIVE reported third-quarter revenue of $1.052 million, down from $4.82 million last year.
The net loss per share narrowed from $39.07 to $13.51. Analysts estimated a loss of $16 per share.
The stock was down 17.4% at $3.70 at the time of publication.
On The Radar
Society For Immunotherapy Of Cancer Annual Meeting Presentations
- Celldex Therapeutics, Inc. CLDX: Phase 1 data for CDX-1140 in solid tumors.
- CELYAD SA/ADR CYAD: Phase 1 data for CYAD-01 and FOLFOX in colorectal cancer.
- Alkermes Plc ALKS: Phase 1/2 data for ALKS 4230 in solid tumors and ALKS 4230 in combination with Merck & Co., Inc. MRK's Keytruda in solid tumors.
- Iovance Biotherapeutics Inc IOVA: data from Cohort 2 of Phase 2 study of LN-144-lifileucel in refractory metastatic melanoma.
- Agenus Inc AGEN: subset analysis of Phase 1 dose escalation study of AGEN2034 in cervical cancer.
- Corvus Pharmaceuticals Inc CRVS: updated Phase 1 data for CPI-006 in solid tumors.
- Apellis Pharmaceuticals Inc APLS: initial Phase 2 data for APL-2 subcutaneous formulation in complement-dependent nephropathies.
- IMMUTEP LTD/S ADR IMMP: Phase 2 data for eftilagimod alpha and Keytruda in non-small cell lung cancer and head and neck cancer.
- Heat Biologics Inc HTBX: Phase 2 data for HS-110 and Bristol-Myers Squibb Co BMY's Opdivo in non-small cell lung cancer.
- Replimune Group Inc REPL: Phase 1 data for RP1 and Opdivo in solid tumors.
- Jounce Therapeutics Inc JNCE: Phase 1 data for JTX-4014 in solid tumors.
- Oncolytics Biotech, Inc. ONCY: interim Phase 1b data for Pelareorep and Roche's Tecentriq in breast cancer.
American Society Of Nephrology Kidney Week Presentations
- Allena Pharmaceuticals Inc ALNA: Phase 2 data for reloxaliase, or ALLN-177, in primary hyperoxaluria and Phase 3 data for reloxaliase in enteric hyperoxaluria.
- Cara Therapeutics Inc CARA: already presented Phase 3 data for Korsuva injection in chronic kidney disease patients on hemodialysis with moderate-to-severe pruritus.
- FibroGen and AstraZeneca: Phase 3 data for Roxadustat for anemia in chronic kidney disease.
American Association For the Study Of Liver Diseases Liver Meeting Presentations
- Ionis Pharmaceuticals Inc IONS: Phase 2 data for IONIS-HBV-ex for hepatitis B virus.
Obalon Therapeutics Inc OBLN (before the market open)
Ocugen Inc OCGN (before the market open)
PLx Pharma Inc PLXP (before the market open)
Selecta Biosciences Inc SELB (before the market open)
Recro Pharma Inc NASDAQ: REPH) (before the market open)
Neos Therapeutics Inc NASDAQ: NEOS) (before the market open)
CNS Pharmaceuticals, which develops therapies for brain cancer and other CNS tumors, priced its 2.125-million share IPO at $4 a share, at the lower end of the estimated price range of $4-$5. The shares are to be listed on the Nasdaq under the ticker "CNSP."
Tela Bio, which sells soft tissue implants used in hernia repair and reconstructive surgery, priced its IPO of 4 million shares at $13 each, below the estimated price range of $14-$15. The company expects to list the shares on the Nasdaq under the ticker "TELA."
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