The Daily Biotech Pulse: ObsEva Surges On Out-Licensing Deal, EyeGate Appoints New CEO, 2 Positive Catalysts For Merck, Candel Therapeutics Debuts

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 July 26)

Absci, CORP ABSI (IPOed Thursday)
Arvinas, Inc. ARVN
BioNTech SE BNTX (disclosed plans to make mRNA vaccine for malaria by 2022)
Cassava Sciences, Inc. SAVA (announced positive data for SavaDx, an investigational diagnostic/biomarker to detect Alzheimer's disease with a simple blood test)
Eli Lilly and Company LLY
Moderna, Inc. MRNA
Monte Rosa Therapeutics, Inc. GLUE
NanoVibronix, Inc. NAOV (announced first shipment of its next generation pain management device, PainShield Plus)
Oramed Pharmaceuticals Inc. ORMP
Sight Sciences, Inc. SGHT (IPOed July 15)
Translate Bio, Inc. TBIO (moved on positive analyst action)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 26)

23andMe Holding Co. ME
AbCellera Biologics Inc. ABCL
Achilles Therapeutics plc ACHL
Acurx Pharmaceuticals, Inc. ACXP
Adaptimmune Therapeutics plc ADAP
Adicet Bio, Inc. ACET
Akouos, Inc. AKUS
Aptose Biosciences Inc. APTO
Ardelyx, Inc. ARDX
Ascendis Pharma A/S ASND
Atai Life Sciences N.V. ATAI
Athenex, Inc. ATNX (announced out-licensing agreement for tirbanibulin)
Avenue Therapeutics, Inc. ATXI
Aytu Biopharma, Inc. AYTU
Biomea Fusion, Inc. BMEA
BioXcel Therapeutics, Inc. BTAI
Black Diamond Therapeutics, Inc. BDTX
Bolt Biotherapeutics, Inc. BOLT
CASI Pharmaceuticals, Inc. CASI
Cellectis S.A. CLLS
Cullinan Oncology, Inc. CGEM
CytomX Therapeutics, Inc. CTMX
Deciphera Pharmaceuticals, Inc. DCPH
DiaMedica Therapeutics Inc. DMAC
Ensysce Biosciences, Inc. ENSC
Epizyme, Inc. EPZM
Esperion Therapeutics, Inc. ESPR
Evoke Pharma, Inc. EVOK
EyeGate Pharmaceuticals, Inc. EYEG
FibroGen, Inc. FGEN
Flexion Therapeutics, Inc. FLXN
Freeline Therapeutics Holdings plc FRLN
Gemini Therapeutics, Inc. GMTX
Global Blood Therapeutics, Inc. GBT
Harpoon Therapeutics, Inc. HARP
HOOKIPA Pharma Inc. HOOK
Ikena Oncology, Inc. IKNA
Imago BioSciences, Inc. IMGO (IPOed July 16)
Inhibikase Therapeutics, Inc. IKT (received Food and Drug Administration clearance for Phase 1b extension study to IkT-148009 in Parkinson's patients)
Insmed Incorporated INSM
InspireMD, Inc. NSPR
iRhythm Technologies, Inc. IRTC
Liminal BioSciences Inc. LMNL
Lyell Immunopharma, Inc. LYEL
Lyra Therapeutics, Inc. LYRA
Madrigal Pharmaceuticals, Inc. MDGL
Mersana Therapeutics, Inc. MRSN
Metacrine, Inc. MTCR
Minerva Neurosciences, Inc. NERV
Mirum Pharmaceuticals, Inc. MIRM
MorphoSys AG MOR (narrowed its revenue guidance for the first-half of 2021)
Neoleukin Therapeutics, Inc. NLTX
NextCure, Inc. NXTC
Nymox Pharmaceutical Corporation NYMX
OncoSec Medical Incorporated (NASDAQ ONCS)
Orchard Therapeutics plc ORTX
ORIC Pharmaceuticals, Inc. ORIC
Oyster Point Pharma, Inc. OYST
Pluristem Therapeutics Inc. PSTI
Praxis Precision Medicines, Inc. PRAX
Protara Therapeutics, Inc. TARA
Relmada Therapeutics, Inc. RLMD
Rockwell Medical, Inc. RMTI
Sage Therapeutics, Inc. SAGE
Sigilon Therapeutics, Inc. SGTX
Soleno Therapeutics, Inc. SLNO
Sonnet BioTherapeutics Holdings, Inc. SONN
Taysha Gene Therapies, Inc. TSHA
TCR2 Therapeutics Inc. TCRR
Terns Pharmaceuticals, Inc. TERN
Trevena, Inc. TRVN
TScan Therapeutics, Inc. TCRX (IPOed July 16)
VectivBio Holding AG VECT
Vor Biopharma Inc. VOR
Yumanity Therapeutics, Inc. YMTX

Stocks In Focus

ObsEva Out-Licenses Preterm Labor Treatment Candidate to Organon For Up To $500M

Organon & Co. OGN and ObsEva SA OBSV announced the companies have entered into an agreement whereby Organon will license the global development, manufacturing and commercial rights to ebopiprant, an investigational compound being evaluated as a potential treatment for preterm labor by reducing inflammation and uterine contractions.

If approved, it has potential to be a first-in-class innovation for this common and serious condition with no approved therapies for acute treatment of preterm labor in the U.S., the companies said.

ObsEva is entitled to receive tiered double-digit royalties on commercial sales as well as up to $500 million in upfront and milestone payments, including $25 million to be paid at signing, up to $90 million in development and regulatory milestones and up to $385 million sales-based milestones.

ObseEva shares were rallying 28.57% to $3.24 in premarket trading.

Mirum Licenses Liver Disease Drug Rights To South Korea's GC Pharma

Mirum and GC Pharma announced an exclusive licensing agreement pursuant to which GC Pharma has agreed to develop and commercialize maralixibat in South Korea. Maralixibat, Mirum's lead candidate, is an investigational, orally administered medication being evaluated in Alagille syndrome, progressive familial intrahepatic cholestasis, and biliary atresia.

In exchange, Mirum is entitled to receive an upfront payment of $5 million as well payments for the achievement of future regulatory and commercial milestones, with tiered double-digit royalties based on product net sales in the region.

EyeGate Appoints Brian Strem As CEO, Signs Letter Of Intent To Buy Bayon Therapeutics

EyeGate Pharmaceuticals, Inc. EYEG announced that Brian Strem, co-founder and managing director of Bayon Therapeutics, was appointed as permanent president, CEO and board member, effective immediately.

Additionally, EyeGate said it has entered a non-binding letter of intent to acquire Bayon Therapeutics, a private ophthalmic specialty pharmaceutical company focused on using light sensitive "photoswitch" small molecules, specifically designed to restore vision in patients with inherited and age-related degenerative retinal diseases.

The stock was jumping 106.09% to $6.43 in premarket trading.

Cerecor Reports Positive Early Stage Results For Crohn's Disease Study

Cerecor Inc. CERC announced positive initial results from a Phase 1b proof-of-concept study evaluating CERC-002 in adult patients with moderate to severe Crohn's disease.

The investigational asset showed positive results for the low-dose cohort of CERC-002 in moderate to severe Crohn's disease patients who had previously failed three or more lines of biologic therapies, including anti-TNF alpha treatments. Mean reduction in LIGHT levels of approximately 80% compared to baseline signify a dramatic and rapid reduction of LIGHT levels correlating to the pharmacodynamic effect of CERC-002, the company added.

CERC-002 was well tolerated with no drug-related severe adverse events. The company noted that Cohort 2, which is evaluating the 3 mg/kg dose, is fully enrolled, and it expects complete data from the study in the second half of 2021.

In premarket trading, the stock was up 13.31% at $3.15.

Oragenics Inks Licensing Deal To Develop Next-Gen COVID-19 Vaccines

Oragenics, Inc. OGEN announced it has entered into a licensing agreement with the National Research Council of Canada that will enable Oragenics to pursue the rapid development of next-generation vaccines against the SARS-CoV-2 virus and its variants.

The stock was moving up 13.55% at 71 cents in premarket trading.

Regeneron, AstraZeneca To Collaborate On Obesity Research

Regeneron Pharmaceuticals, Inc. REGN and AstraZeneca plc AZN announced the companies have entered into a collaboration to develop small molecule compounds directed against the GPR75 target with the potential to treat obesity and related co-morbidities.

The companies will evenly split R&D costs and share equally in any future potential profits.

In premarket trading, AstraZeneca was up 0.93% at $57.32, while Regeneron was slipping 0.14% at $576.95.

Merck Announces Positive Phase 3 Data For Keytruda-Chemo Combo In First-Line Breast Cancer Treatment, FDA Approval In Neoadjuvant Breast Cancer Setting

Merck & Co., Inc. MRK announced positive overall survival results from the pivotal Phase 3 KEYNOTE-355 trial evaluating Keytruda in combination with chemotherapy for the treatment of patients with metastatic triple-negative breast cancer.

Separately, Merck said the FDA has approved Keytruda for the treatment of patients with high-risk, early stage triple-negative breast cancer in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery, based on the Phase 3 KEYNOTE-522 trial.

Merck shares were up 0.49% at $77.62 in premarket trading.

Centogene Announces Appointment Of Patrice Denèfle As Chief Scientific Officer

Centogene N.V. CNTG announced the appointment of Dr. Patrice Denèfle as chief scientific officer effective Aug.16. Denèfle will take over from Phil Lambert, who has decided to leave the company.

Kiromic Acquires Bioinformatics, AI Company InSilico

Kiromic Biopharma, Inc. KRBP announced the completion of the acquisition of InSilico Solutions, a bio-informatics and artificial intelligence company with a long standing collaborative relationship with its clients at MD Anderson Cancer Center, Johns Hopkins School of Medicine and the National Cancer Institute.

"With this acquisition, Kiromic will bring in-house a team of experts in bioinformatics and AI in order to lengthen its lead in the race for an AI technology with the capability to select the optimal bio-markers needed for cutting edge immunotherapeutics such as CAR-T cell therapy," Kiromic said.

Kiromic shares were rallying 13.10% to $3.54 in premarket trading.

Day One's Lead Candidate Gets Rare Pediatric Disease Designation For Low-Grade Glioma Treatment

Day One Biopharmaceuticals DAWN announced the FDA has granted rare pediatric disease designation to its lead product candidate DAY101 for the treatment of low-grade gliomas harboring an activating RAF alteration that disproportionately affects children.

Tonix Acquires R&D Facility For Expediting Infectious Disease Drug, Vaccine Development

Tonix Pharmaceuticals Holding Corp. TNXP announced an agreement to acquire an approximately 48,000-square-foot R&D facility in Frederick, Maryland to support its expanding infectious disease pipeline, including TNX-1800, a live replicating viral vaccine designed to protect against COVID-19, TNX-801, a live vaccine designed to protect against smallpox and monkeypox, and TNX-3500, a small molecule antiviral to inhibit replication of SARS-CoV-2.

The stock was up 10.48% at 77 cents in premarket trading.

On The Radar

Clinical Readouts

Unity Biotechnology, Inc. UBX: clinical data from the Phase 1 study of a single injection of UBX1325 in patients with diabetic macular edema and wet age-related macular degeneration.

Infinity Pharmaceuticals, Inc. INFI: updates on the MARIO-3 triple negative breast cancer and MARIO-275 ulcerative colitis clinical studies, both of which add eganelisib to approved standard of care regimens.

Earnings

Boston Scientific Corporation BSX (before the market open)
Masimo Corporation MASI (after the close)
Taro Pharmaceutical Industries Ltd. TARO (after the close)

IPOs

Candel Therapeutics, Inc., a Massachusetts-based late clinical stage biopharma focused on helping patients fight cancer with oncolytic viral immunotherapies, said it has priced its upsized offering of 9 million shares at $8 per share. The shares will begin trading on the Nasdaq under the ticker symbol "CADL." The company expects to raise gross proceeds of $72 million from the offering,

Market News and Data brought to you by Benzinga APIs