Biotech week ahead, March 29

 Biotech stocks reversed course and ended lower in the week ended March 26, drawing inspiration from the broader market weakness.

The earnings news flow was confined to micro- and small-cap companies. Five biopharma companies listed their shares on the Nasdaq through initial public offerings. These companies raised about $666.5 million in gross proceeds.

Several Food and Drug Administration approvals came through during the week. Merck's MRK 1.76% Keytruda was cleared for easophageal cancer, while Pacira BioSciences, Inc.'s PCRX 3.03% non-opioid pain drug and Zealand Pharma A/S' ZEAL 9.49% ready-to-use glucagon pen to treat low blood sugar levels also received clearance from the FDA.

A T-cell therapy co-developed by bluebird bio Inc BLUE 1.25% and Bristol-Myers Squibb Co BMY 1.88% won the nod for a type of myeloma skin cancer.

Odonate Therapeutics, Inc. ODT 14.4% was among the worst performers of the week after it shelved the study of its oral chemotherapy medication in breast cancer and also decided to wind down operations.
Frequency Therapeutics, Inc. FREQ 4.62% was another big loser after its shares shed about 80% of their value following the release of an adverse clinical readout.

Here are the key catalysts for the unfolding week:

Conferences

Stifel 3rd Annual CNS Day: March 31
Guggenheim Healthcare Talks: 2021 Genomic Medicines & Rare Disease: April 1

PDUFA Dates

ACADIA Pharmaceuticals Inc.'s ACAD 0.61% regulatory application seeking expanded use of pimavanserin has a decision date of Saturday, April 3. The company is hoping to get approval for the additional indication of hallucinations and delusions associated with dementia-related psychosis.

But it looks likely there will be either a delay in approval or an outright rejection. The company announced on March 8 that the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements or commitments.

Clinical Readouts/Presentations

Pending Readouts For March/ Q1/Early 2021

Sage Therapeutics, Inc. SAGE 3.22% expects to release sometime soon topline data from a Phase 2 KINETIC study that is evaluating its SAGE-324 in patients with a nervous disorder called essential tremor. It also expects to release topline data from a Phase 2a study of SAGE-718 in patients with Parkinson's disease cognitive dysfunction.

Merck & Co., Inc. MRK 1.76% will release in the first quarter full results from a Phase 3 study of MK-7110, a therapeutic candidate for the treatment of patients with severe and critical COVID-19. MK-7110 came into Merck's stable through its acquisition of OncoImmune.

Delcath Systems, Inc. DCTH 0.42% is scheduled to release topline results from the Phase 3 study of Hepzato kit in liver dominant ocular melanoma. Hepzato kit consists of melphalan hydrochloride for injection or hepatic delivery, and it is meant to deliver high-dose chemotherapy to the liver while minimizing systemic exposure and associated side effects.

Yumanity Therapeutics, Inc. YMTX 2.87% is due to release results from the Phase 1 multiple-ascending dose study of its investigational therapy YTX-7739 in healthy volunteers. YTX-7739 is being evaluated for the treatment of Parkinson's disease.

BioXcel Therapeutics, Inc. BTAI 0.92% will release in the first quarter topline results from the Phase 1b/2 study of BXCL501 for the treatment of opioid withdrawal symptoms.

Wave Life Sciences Ltd. WVE 2.78% is due to release at the end of the first quarter, data from ongoing PRECISION-HD and OLE clinical trials evaluating WVE-120101 in Huntington's disease.

Forma Therapeutics Holdings, Inc. FMTX 9.45% is expected to release in the first quarter, data from the 600mg cohort of the multiple-ascending dose 2 part of the Phase 1 study of FT-4202 in sickle cell disease patients.

Celldex Therapeutics, Inc. CLDX 8.62% is scheduled to release in the first quarter Phase 1b study of CDX-0159 in chronic inducible urticaria – an allergic skin reaction.

AzurRx BioPharma, Inc. AZRX 2.96% will release by the end of the first quarter topline data from the Phase 2b OPTION 2 study of MS1819 in cystic fibrosis patients with exocrine pancreatic insufficiency.

Humanigen, Inc. HGEN 1.67% is scheduled to release at the end of March topline data from the Phase 3 study of lenzilumab in COVID-19.

New Drug Application Filings

Alnylam Pharmaceuticals, Inc. ALNY 0.75% is scheduled to file a new drug application for vutrisiran in early 2021. The drug is a subcutaneously administered investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis. ATTR amyloidosis is related to the abnormal production and buildup of a type of a protein called transthyretin, which is used to transport thyroid hormones and vitamin A throughout the body.

CTI BioPharma Corp. CTIC 0.36% expects to complete a rolling submission of its NDA for pacritinib, for use in myelofibrosis patients with severe thrombocytopenia before the end of March.

Earnings

Monday

Matinas BioPharma Holdings, Inc. MTNB 0.91% (before the market open)
I-Mab IMAB 1.19% (before the market open)
F-star Therapeutics, Inc. FSTX 7.15% (before the market open)
Biocept, Inc. BIOC 4.41% (after the close)

Tuesday

PolarityTE, Inc. PTE 1.77% (before the market open)
Pieris Pharmaceuticals, Inc. PIRS 0.78% (before the market open)
Forma Therapeutics (before the market open)
Protalix BioTherapeutics, Inc. PLX 1.05% (before the market open)
AngioDynamics, Inc. ANGO (before the market close)
Bellicum Pharmaceuticals, Inc. BLCM 0.25% (after the close)
Daré Bioscience, Inc. DARE 3.89% (after the close)
IGM Biosciences, Inc. IGMS 6.02% (after the close)
Osmotica Pharmaceuticals plc OSMT 2.36% (after the close)
EDAP TMS S.A. EDAP 4.62% (after the close)
Dyadic International, Inc. DYAI 4.09% (after the close)
Crinetics Pharmaceuticals, Inc. CRNX 2.76% (after the close)

Wednesday

Apyx Medical Corporation APYX 2.58% (before the market open)
Delcath Systems (before the market open)
BiomX Inc. PHGE 1.11% (before the market open)
Precipio, Inc. PRPO 2.92% (after the close)
Rockwell Medical, Inc. RMTI 2.08% (after the close)

IPOs

IPO Pricing

U.K.-based Achilles Therapeutics plc has filed with the SEC to sell 9.75 million American depositary shares in an initial public offering, with each ADS representing one ordinary share of the company. The clinical stage immuno-oncology company is developing precision T-cell therapies to treat multiple types of solid tumors. The company plans to price the offering between $17 and $19. It has applied for listing its shares on the Nasdaq under the ticker symbol ACHL.

https://www.benzinga.com/general/biotech/21/03/20371081/the-week-ahead-in-biotech-march-28-april-3-acadias-dementia-drug-update-clinical-readouts-few-ear

Germany expects first delivery of J&J COVID-19 shot in mid-April

 Germany is due to receive the first small delivery of Johnson & Johnson's single dose COVID-19 vaccine in mid-April, Health Minister Jens Spahn said on Saturday, giving the country a further shot to help speed up its sluggish rollout.

"It will only be a small delivery at first," Spahn told an online event, adding he expected a shipment of around 275,000 doses in the week of April 12.

"But at least - because we have been waiting a long time for the first delivery from J&J - we will get the first deliveries of the vaccine in mid-April, and it will then be ramped up to millions of doses, as is the case with all deliveries."

J&J's shot, which was approved by European Union regulators on March 11, is the fourth to be endorsed for use in the EU after vaccines from Pfizer-BioNTech,, AstraZeneca-Oxford University and Moderna.

After a sluggish start to its vaccine rollout, hampered by delivery delays and supply constraints, Germany hopes to ramp up vaccinations from next month when it expects to receive 15 million doses from the three other suppliers.

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/news/Moderna-nbsp-Germany-expects-first-delivery-of-J-J-COVID-19-shot-in-mid-April-32819924/

Beijing and UAE to work together on affordable vaccines

 China wants to work with the United Arab Emirates on the production of affordable COVID-19 vaccines, the country’s top diplomat told the Emirates state news agency WAM on Saturday.

“We will work to expedite the bilateral production of the vaccines in a way that would contribute greatly to making sure the vaccines are available and affordable,” China’s Foreign Minister Wang Yi said, kicking off a two-day official visit to the UAE, part of a wider regional tour.

The UAE was the first country outside China to roll out the Chinese-made Sinopharm vaccine in December 2020, saying it had 86% efficacy citing results from late-stage clinical trials.

Wang landed in the UAE from Tehran, where he signed a landmark 25-year cooperation agreement with his Iranian counterpart.

https://www.reuters.com/article/us-health-coronavirus-emirates-china/chinese-fm-beijing-and-uae-to-work-together-on-affordable-vaccines-idUSKBN2BJ0H3

Serum Institute delays expected launch of Novavax vaccine in India

 The launch in India of a new COVID-19 vaccine developed jointly by the Serum Institute of India and U.S.-based biotech firm Novavax is likely to be delayed to September, the Indian company's boss said on Saturday.

Adar Poonawalla, the chief executive of Serum, said in January that the vaccine, named Corovax, was expected to be launched by June.

On Saturday Poonawalla said the trials of Corovax had kicked off in India, but did not say why the vaccine launch was delayed.

"It has been tested against African and UK variants of #COVID19 and has an overall efficacy of 89%," tweeted Poonawalla, whose Serum Institute is the world's largest manufacturer of vaccines.

"Hope to launch by September 2021!"

Poonawalla said earlier this month that a temporary U.S. ban on exports of critical raw materials could limit the production of coronavirus vaccines such as Novavax.

India, the world's biggest vaccine maker, said on Friday it would prioritise domestic COVID-19 inoculations amid rising coronavirus case and had told international buyers of its decision.

The South Asian nation, which has exported 60.5 million does, has not banned exports outright.

India has injected 58.1 million vaccine doses, the third highest figure after the United States and Brazil, although much lower as a proportion of its population of 1.35 billion.

On Saturday former Indian cricket captain Sachin Tendulkar said he had contracted the coronavirus, as the country reported 62,258 new infections in the previous 24 hours, its highest daily rate since October, taking its tally to 11.91 million.

The death toll from the pandemic rose by 291 to stand at 161,240.

https://www.marketscreener.com/quote/stock/NOVAVAX-INC-58256108/news/Novavax-nbsp-Serum-Institute-delays-expected-launch-of-Novavax-vaccine-in-India-32819670/

Brazil posts record 3,650 new COVID-19 deaths, unveils two homegrown vaccines

 Brazil posted a record 3,650 new COVID-19 deaths on Friday, and the country also unveiled its first two domestically developed COVID-19 vaccine candidates for human trials, which although months away from use, should eventually help tame the pandemic.

More than 300,000 have died from COVID-19 in Latin America’s biggest country. It is the world’s second highest total after the United States, making Brazil the global epicenter of the outbreak due to a lack of federal restrictions, an infectious new variant and a patchy vaccine rollout.

Friday’s record death toll was the second this week, with a historic 100,158 new coronavirus cases on Thursday.

Pressure has been mounting on President Jair Bolsonaro to tackle a public health crisis he has minimized, shunning masks, railing against lockdowns and sowing doubts about vaccines.

Bolsonaro, a far-right former army captain, has begun to change his tone on vaccines that he had previously said he would not take.

On Friday, Brazil health regulator Anvisa said it had received a request to start phase 1-2 testing of a vaccine known as Versamune, developed by the University of Sao Paulo Ribeirão Preto, in conjunction with Farmacore and PDS Biotechnology.

Brazil’s Science, Technology and Innovation Minister Marcos Pontes said the Versamune vaccine was one of three federally supported shots.

Earlier, Sao Paulo’s Butantan biomedical institute said it will seek approval to begin human trials for its own vaccine with the goal to begin inoculations in July. That would be an aggressive timeline even considering the recent race for COVID-19 shots.

Butantan aims to produce 40 million doses of the Butanvac vaccine this year, starting in May, officials said, which would help a sputtering national immunization program.

Doria told a news conference that Butanvac production will not interfere with the state-funded institute’s partnership to produce and distribute a COVID-19 shot developed by China’s Sinovac Biotech Ltd.

Butantan officials said the new vaccine had been designed to protect against the contagious P1 variant of the coronavirus, which emerged in the Amazon region last year and is fueling a deadly second wave of cases overwhelming hospitals.

The vaccine was developed using a modified virus, which causes the Newcastle disease in birds, to elicit an immune response to a spike protein from the novel coronavirus.

Butantan plans to test the vaccine on 1,800 volunteers over two phases, two people familiar with the matter told Reuters ahead of the official announcement.

https://www.reuters.com/article/us-health-coronavirus-brazil-vaccine/brazil-posts-record-3650-new-covid-19-deaths-unveils-two-homegrown-vaccines-idUSKBN2BI1KF

UK plans COVID-19 vaccine boosters for people over-70s from September

 Britain is planning booster COVID-19 vaccines for over 70 year olds from September to protect them from new virus variants as the government drives ahead with its vaccine rollout, The Telegraph reported on Friday, citing the vaccine deployment minister.

"The most likely date will be September. Jonathan Van-Tam (the deputy chief medical officer) thinks that if we are going to see a requirement for a booster jab to protect the most vulnerable, (it) would be around September," British Vaccine Deployment Minister Nadhim Zahawi told the paper here.

The booster COVID-19 vaccine will be given to those aged over 70 as well as frontline NHS and social care workers, the report added.

UK government and Public Health England were not immediately available to Reuters request for comment.

https://www.reuters.com/article/us-health-coronavirus-britain-vaccines/uk-plans-covid-19-vaccine-boosters-for-people-over-70s-from-september-the-telegraph-idUSKBN2BI37P

Britain reported nearing vaccine deal with EU

 Britain is close to striking a vaccine deal with the European Union as soon as this weekend that will remove the threat of the bloc cutting off supplies, The Times reported on Saturday.

Under the agreement the EU will remove its threat to ban the export of Pfizer-BioNTech vaccines to Britain, it added.

In return, the UK government will agree to forgo some long-term supplies of the Oxford-AstraZeneca vaccine that had been due to be exported from Holland, the newspaper reported.

On Friday, the European Medicines Agency approved Halix production site in the Netherlands that makes the AstraZeneca vaccine and a facility in Marburg in Germany producing BioNTech/Pfizer shots.

The EU’s clearing of the vaccine site comes as the union is banking on them to boost deliveries in the second quarter and accelerate the slow pace of inoculations in the bloc.

Europe’s troubled vaccine rollout has led to a quarrel with Britain, which has imported 21 million doses made in the EU, according to an EU official. Britain says it did a better job negotiating with manufacturers and arranging supply chains.

The EU says that Britain should share more, notably to help make up the shortfall in contracted deliveries of AstraZeneca shots.

Brussels and London sought to cool tensions on Wednesday, declaring they were working “to create a win-win situation and expand vaccine supply for all our citizens”.

The UK government, Pfizer-BioNTech, and AstraZeneca were not immediately available for comment after office hours.

https://www.reuters.com/article/us-health-coronavirus-britain-eu/britain-nearing-vaccine-deal-with-european-union-the-times-idUSKBN2BJ01K