The Daily Biotech Pulse: Regulatory Setback For Fennec Pharma, Ligand To Buy Pfenex, Inovio Says Phase 2/3 Coronavirus Vaccine Study Starts In September

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Aug. 10)

• Allovir Inc ALVR
• BioLife Solutions Inc BLFS
• BioSpecifics Technologies Corp. BSTC (reacted to second-quarter results)
• CymaBay Therapeutics Inc CBAY
• Eton Pharmaceuticals Inc ETON
• Fennec Pharmaceuticals Inc FENC
• Fulgent Genetics Inc FLGT
• Harvard Bioscience, Inc. HBIO
• Inari Medical Inc NARI
• Kura Oncology Inc KURA
• Omeros Corporation OMER (announced positive results for the study of its lead asset in COVID-19)
• Pacira Biosciences Inc PCRX
• RedHill Biopharma Ltd RDHL
• Rocket Pharmaceuticals Inc RCKT
• Seres Therapeutics Inc MCRB (reacted to positive late-stage clinical readout)
• Silk Road Medical Inc SILK
• Sorrento Therapeutics Inc SRNE
• Trevena Inc TRVN (announced FDA nod for pain drug)
• Unity Biotechnology Inc UBX
• Vaxcyte Inc PCVX

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Aug. 10)

• Checkmate Pharmaceuticals Inc CMPI (went public Friday)
• Freeline Therapeutics Holdings plc ADS FRLN (went public Friday)
• Lantern Pharma Inc. LTRN
• Nkarta Inc NKTX
• Recro Pharma Inc REPH (reacted to second-quarter results)

Stocks In Focus

Equillium Announces Positive Interim Data For Lead Drug, Requests Pre-IND Meeting For COVID-19 Study

Equillium Inc EQ announced positive interim data from the first two cohorts of the Phase 1b open label, dose escalation portion of the EQUATE study of itolizumab in acute graft-versus-host disease. 

Across the first two dose cohorts, itolizumab has been generally well-tolerated to date, and five of seven patients achieved a complete response by day 29, the company said.

Additionally, Equillium said it has submitted a request to the FDA for a pre-IND meeting to review its proposal to initiate a global randomized controlled clinical trial to study itolizumab in hospitalized patients with COVID-19.

The stock was trading 21.29% higher premarket Tuesday at $12.19. 

Clearside's IND Application Approved For Wet AMD Study 

Clearside Biomedical Inc CLSD said the FDA has accepted its IND application for CLS-AX, enabling initiation of a Phase 1/2a clinical trial of CLS-AX in neovascular age-related macular degeneration patients by the end of 2020.

The dose-escalation study will assess the safety and tolerability of single doses of CLS-AX administered through suprachoroidal injection following two or more prior treatments with an intravitreal anti-VEGF agent, according to the company. 

Separately, the company announced second-quarter results, reporting an increase in license revenue from $45,000 in 2019 to $354,000 in 2020. The net loss per share narrowed from 15 cents to 13 cents, but was wider than the 12-cent-per-share loss expected by analysts.

The stock was up 7.26% at $1.92 premarket Tuesday.

Innate Pharma Receives French Government Funding For COVID-19 Research

Innate Pharma SA IPHA said it has received 6.8 million euros ($8 million) in funding from the French government to support its COVID-19 R&D activities.

The company said it expects the funding to help cover the development of the COVID-19 activities it began in March 2020, including the EXPLORE COVID-19 translational research study and its two Phase 2 clinical trials, FORCE and ImmunONCOVID-20.

Fennec Handed Complete Response Letter For Drug To Treat Chemotherapy-Induced Ototoxicity

Fennec Pharma said it received a complete response letter Monday from the FDA regarding its NDA for Pedmark, a unique formulation of sodium thiosulfate, for intravenous administration for the prevention of ototoxicity associated with cisplatin chemotherapy in pediatric patients with localized, non-metastatic solid tumors.

The stock was plunging 28.42% premarket to $7.28.

See also: The Week Ahead In Biotech: Bausch Health, Fennec Pharma FDA Decisions And Smid-cap Earning

Catalyst's Firdapse Flunks Late-Stage Study In Neuromuscular Disease

Catalyst Pharmaceuticals Inc CPRX said the top-line results from its Phase 3 study for Firdapse in anti-MuSK antibody positive myasthenia gravis patients did not replicate the robust positive results that were observed in the 2017 proof-of-concept study. The study did not meet the primary or secondary endpoints.

The company also reported second-quarter results, showing a modest increase in revenue but a decline in EPS, which beat the consensus estimate by a penny.

The stock was down 11.14% at $3.79 premarket. 

Ligand To Buy Pfenex For Up To $516M

Ligand Pharmaceuticals Inc. LGND and Pfenex Inc PFNX announced the signing of a definitive agreement for Ligand to acquire all outstanding shares of Pfenex for $12 per share in cash or $438 million in equity value on a fully diluted basis.

Additionally, Ligand will pay $2 per share or $78 million as a contingent value right in the event a predefined regulatory milestone is achieved by Dec. 31, 2021, for a total transaction value of up to $516 million. The transaction is expected to close in the fourth quarter.

In premarket trading, Pfenex shares were jumping 63.45% to $12.52.

Mesoblast Slumps As FDA Raises Questions Over Stem Cell Efficacy In Graft-Versus-Host Disease

Shares of stem cell therapy company Mesoblast limited MESO moved to the downside after FDA staffers expressed doubts over the adequacy of evidence for the efficacy of the company's remestemcel-L for treating acute graft-versus-host disease in children.

The comments came in a briefing document released ahead of an Adcom meeting. The FDA's Oncologic Drugs Advisory Committee is scheduled to meet Thursday to discuss the BLA submitted by the company.

The stock was down 25.66% at $12.95 premarket Tuesday.

Inovio To Commence Late-Stage Coronavirus Vaccine Study In September, Q2 Results Trail Estimates

Inovio Pharmaceuticals Inc INO said it looks forward to starting a Phase 2/3 coronavirus vaccine study in the U.S. in September.

The company reported second-quarter revenue of $267,187 in 2020 compared to $135,673 in 2019. The loss per share widened from 30 cents to 83 cents. Analysts estimated a loss of 17 cents per share on revenue of $2.61 million.

The stock was down 11.01% at $16.90 premarket Tuesday. 

Earnings

ICU Medical Inc's ICUI second-quarter revenue fell from $312.3 million in 2019 to $303.4 million, and adjusted EPS fell from $1.99 to $1.65. The results, however, exceeded expectations.

Separately, the company announced a long-term agreement with Grifols SA - ADR ADR Class B GRFS to distribute a full line of non-PVC/non-DEHP IV containers for 0.9% sodium chloride injections in the U.S. 

Omeros said its second-quarter revenue fell from $26.8 million in 2019 to $13.5 million in 2020, with the downside blamed on the postponement of cataract procedures by ASCs and hospitals due to COVID-19.

The net loss per share narrowed from 61 cents to 29 cents. The revenue missed estimates and the net loss per share was wider than the consensus estimate.

Separately, the company said it has commenced concurrent underwritten public offerings of $125 million shares of its common stock and $200 million in an aggregate principal amount of convertible senior notes due 2026.

The stock was down 7.83% at $19.65 premarket Tuesday.

Offerings

PDS Biotechnology Corp PDSB said it intends to offer shares of its common stock in an underwritten public offering. All of the shares in the offering are to be sold by the company.

The stock was down 20.92% at $3.10 premarket Tuesday.

On The Radar

PDUFA Dates

The FDA's decision on label expansion for Roche Holdings AG's Basel ADR Common Stock RHHBY Xolair for the treatment of nasal polyps could arrive, as the company is 10 months out from the submission of the sBLA.

Earnings

• BioNTech SE – ADR BNTX (before the market open)
• STRATA Skin Sciences Inc SSKN (before the market open)
• Surface Oncology Inc SURF (before the market open)
• Prevail Therapeutics Inc PRVL (before the market open)
• Generation Bio Co GBIO (before the market open)
• Fulcrum Therapeutics Inc FULC (before the market open)
• Affimed NV AFMD (before the market open)
• Burning Rock Biotech Ltd BNR (before the market open)
• Gamida Cell Ltd GMDA (before the market open)
• 10X Genomics Inc TXG (after the market close)
• Agile Therapeutics Inc AGRX (after the market close)
• Aethlon Medical, Inc. AEMD (after the market close)
• T2 Biosystems Inc TTOO (after the market close)
• Cumberland Pharmaceuticals, Inc. CPIX (after the market close)
• DiaMedica Therapeutics Inc DMAC (after the market close)
• HTG Molecular Diagnostics Inc HTGM (after the market close)
• Sunesis Pharmaceuticals, Inc. SNSS (after the market close)
• Shockwave Medical Inc SWAV (after the market close)
• RA Medical Systems Inc RMED (after the market close)
• Inari Medical (after the market close)

Related Link: Attention Biotech Investors: Mark Your Calendar For August PDUFA Dates