On Heels of bluebird bio Collaboration, Gritstone Secures $100 Million in IPO

Emeryville, Calif.-based Gritstone Oncology hits the ground running today on the Nasdaq Exchange after raising $100 million in an initial public offering.

Gritstone, which will sell under the ticker symbol GRTS, sold 6.6 million shares of common stock at $15 per share, the company announced Thursday. Additionally, Gritstone Oncology said it has granted the underwriters a 30-day option to purchase up to an additional 1,000,000 shares of common stock at the initial public offering price. Goldman Sachs & Co. LLC, Cowen and Company, LLC and Barclays Capital Inc. acted as joint book-running managers for the offering. BTIG, LLC acted as lead manager for the offering, Gritstone said.

Gritstone, which launched in 2015, is the latest in a string of biotech companies to go public this year and the fourth this week. Gritstone follows Kodiak Sciences, Eli Lilly’s Elanco Animal Health and Lexington, Mass.-based Aldeyra Therapeutics with IPOs this week. Combined the companies secured more than half-a-billion from their IPOs.

And there are more biotech IPOs expected in the coming weeks. On Monday BioSpace highlighted five companies that will soon make the IPO plunge. The companies are Entasis Therapeutics, Urovant Sciences, Ra Medical Systems, Sutro Biopharma and New Haven, Conn.-based Arvinas. Additionally, Pennsylvania-based PhaseBio filed a prospectus for an $86 million IPO. Last week New York-based Y-mAbs Therapeutics secured $96 million through an initial public offering

Founded by Clovis Oncology’s Andrew Allen, Gritstone is making its IPO splash hard on the heels of the company’s collaborative deal with bluebird bio. Last month the Bay Area Gritstone inked a deal with Cambridge, Mass.-based bluebird to combine gene and cell therapies to target cancer. Gritstone will used its artificial intelligence platform known as EDGE to analyze specific tumor types for the collaboration. Gritstone’s therapeutic approach sequences the DNA of cancer patients in order to identify specific mutations. Then, the company chooses the makers that will act as the best neo-antigens that will be synthesized in a lab for use as an immunotherapy. Under the agreement, Gritstone will identify 10 tumor-specific targets across several tumor types. EDGE will be used to identify tumor-specific targets and natural T-cell receptors (TCRs) directed to those targets for use in bluebird bio’s established cell therapy platforms.

The collaboration with bluebird came only a month after Gritstone struck a deal with another powerhouse – Bristol-Myers Squibb. Gritstone and Bristol-Myers Squibb struck a deal to evaluate the safety and tolerability of Gritstone’s personalized neoantigen immunotherapy called GRANITE-001 paired with BMS’ checkpoint inhibitor Opdivo. GRANITE-001 includes sequential delivery of neoantigens to patients within an adenovirus-based vector (prime) and a self-replicating RNA-based vector. The combination will be explored for its potential treatment of solid tumors.

https://www.biospace.com/article/on-the-heels-of-bluebird-bio-collaboration-gritstone-secures-100-million-in-ipo/

Aimmune and DBV Eye the Finish Line for Peanut Allergy Treatments

An estimated 15 million people in the United States have allergies to more than 170 different foods, according to the non-profit Food Allergy Research and Education. New health data suggests the frequency of food allergies in children under 18 has risen 70 percent since 1997, CNBC reported.

With the rise in food allergies, there are a number of biopharma companies driving forward with medications that can help people augment their immune systems to avoid or minimize allergic reactions to certain foods. This year several companies are expected to file for regulatory approval of medications aimed at addressing these issues, particularly peanut allergies. There are currently no approved treatments for peanut allergies, which is the leading cause of food-induced allergic death in the United States.

By the end of the year, Brisbane, Calif.-based Aimmune intends to file a Biologics License Application for its peanut allergy treatment, AR101. Aimmune’s AR101 is an oral biologic desensitization therapy that is sprinkled over food before eating. In February, Aimmune released Phase III trial data that showed its peanut allergy therapy was effective in more than 67 percent of juvenile patients. Aimmune said 67.2 percent of juveniles ages four to 17 who were administered AR101 in the Palisade trial could tolerate exposure of at least a 600-mg dose of peanut protein in the exit food challenge. Only 4 percent of patients on the placebo could tolerate that amount, the company said.

This morning, CNBC noted that if Aimmune’s therapy is approved by the FDA, the company could see peak sales of $.13 billion by 2025.

Days after Aimmune announced its positive late-stage peanut allergy data, French company DBV Technologies announced it saw positive outcomes from its milk allergy trial. Milk allergiesare among the most common in children, affecting between 2 to 3 percent of the population. Reactions can range from mild to severe.

The mid-stage trial showed that DBV Technology’s Viaskin Milk product yielded successful results in patients suffering from IgE-mediated cow’s milk protein allergy. Data showed that children on DBV’s Viaskin treatment had a statistically significant desensitization to milk after 12 months of treatment. Viaskin is an electrostatic patch, based on Epicutaneous Immunotherapy, which administers an allergen directly onto the skin to activate the immune system by specifically targeting antigen-presenting cells without allowing passage of the antigen into the bloodstream.

Last year DBV reported its Phase III peanut allergy trial failed to show a statistically significant response against placebo. However, in February, the company received permission to seek approval from the FDA, despite the Phase III problems. At the time, Bloomberg reported the FDA “agreed that the available efficacy and safety data” supports the submission of an application that, if approved, would let DBV bring its Viaskin patch to market.

In addition to Aimmune and DBV, pharma giants Regeneron and Sanofi are also eying treatments for peanut allergies. The companies are working with their IL-4 and IL-13 inhibitor Dupixent as a potential treatment for the allergy. Last year perennial development partners Sanofi and Regeneron teamed up with Aimmune to pair AR101 with Dupixent.

https://www.biospace.com/article/aimmune-and-dbv-eye-the-finish-line-for-peanut-allergy-treatments/

Bausch Health unit moves to settle SEC charges it misled investors

Salix Pharmaceuticals, a unit of Bausch Health Companies Inc, has moved to settle charges brought by the U.S. Securities and Exchange Commission that it misled investors about the company’s prospects, the SEC said on Friday.

As part of the proposed settlement, which must be approved by a U.S. district court, Salix agreed to an SEC order to avoid future violations of antifraud and corporate reporting provisions of federal securities laws, the agency said.

A former chief financial officer at Salix, Adam Derbyshire, was also charged and agreed to a settlement in which he will pay more than $1 million, the SEC said. A lawyer for Derbyshire said he had no comment on the settlement.

The alleged misconduct occurred before Salix was acquired by Valeant Pharmaceuticals International, which is now known as Bausch Health, according to the agency.

In a statement, Salix said it was pleased to reach the settlement, and has “completely transformed” since its acquisition by Bausch in 2015.

https://www.marketscreener.com/BAUSCH-HEALTH-COMPANIES-I-44965076/news/Bausch-Health-unit-moves-to-settle-charges-it-misled-investors-SEC-27339745/

Takeda: $62 billion Shire bid faces Nov. 6 EU antitrust deadline

EU antitrust regulators will decide by Nov. 6 whether to allow Japanese drugmaker Takeda Pharmaceutical’s $62-billion takeover of London-listed Shire Plc, the European Commission said on Friday.

The EU competition enforcer can give the green light with or without demanding concessions or open a four-month long investigation if it has serious concerns.

The deal, the largest overseas acquisition by a Japanese company, would elevate the combined company into the list of the top 10 global drugmakers. It would be a leader in gastroenterology, neuroscience, oncology, rare diseases and blood-derived therapies used for serious conditions such as haemophilia.

Authorities in the United States, China and Brazil have already given unconditional approvals for the deal.

https://www.marketscreener.com/TAKEDA-PHARMACEUTICAL-CO-6491073/news/Takeda-Pharmaceutical-62-billion-Shire-bid-faces-November-6-EU-antitrust-deadline-27340262/

ChemoCentryx terminates previously announced common stock offering

ChemoCentryx (NASDAQ:CCXI) will not conclude previously announced common stock offering.

The Company believes that culmination of terms representing the best interests of its stockholders is not to be achieved at the current time.

Shares are up 11% premarket.

Previously: ChemoCentryx launches $75M stock offering (Sept. 26)

https://seekingalpha.com/news/3393626-chemocentryx-terminates-previously-announced-common-stock-offering

Corcept granted orphan status for pancreatic cancer treatment

The FDA granted Corcept Therapeutics orphan status for relacorilant, its treatment of pancreatic cancer

https://thefly.com/landingPageNews.php?id=2797139

Walgreens Boots Alliance to pay $34.M penalty to SEC to resolve probe

Walgreens Boots Alliance announced that the company has reached an agreement with the SEC to fully resolve an investigation into forward-looking financial goals and related disclosures by Walgreen Co. The disclosures at issue were made prior to the merger with Alliance Boots and the establishment of Walgreens Boots Alliance on December 31, 2014. The settlement does not involve any of Walgreens Boots Alliance’s current officers or executives, nor does it allege that anyone acted intentionally or recklessly at any time. In agreeing to the settlement, Walgreens Boots Alliance neither admits nor denies the SEC’s allegations that Walgreens and its then CEO and then CFO acted negligently in connection with statements made in the June 2013, October 2013, December 2013 and March 2014 earnings calls, by failing to adequately disclose the increased risk to achieving certain of Walgreens previously stated fiscal 2016 financial goals. Following warnings in December 2013 and March 2014, Walgreens withdrew those fiscal 2016 goals in June 2014. Pursuant to the agreement with the SEC, Walgreens Boots Alliance consented to the SEC’s issuance of an administrative order, and the company will pay a $34.5M penalty, which has been fully reserved for, while the Walgreens then CEO and then CFO separately resolved the matter with the SEC. Walgreens Boots Alliance cooperated fully with the SEC’s investigation and believes the agreement is in the best interest of the company.
https://thefly.com/landingPageNews.php?id=2797153