Shares of Spectrum Pharmaceuticals Inc. fell nearly 30% on Friday after the U.S. Food and Drug Administration rejected its application for a drug targeting a side effect of some cancer treatments.
Spectrum said the FDA, in a complete response letter, cited manufacturing deficiencies related to the manufacturing of Rolontis and indicated that it will need to reinspect the drug's manufacturing plant in South Korea.
An FDA complete response letter indicates that the agency won't approve an application in its current form.
Spectrum is seeking FDA approval of Rolontis for the treatment of neutropenia, an abnormally low count of a type of white blood cell, in patients receiving myelosuppressive anticancer drugs.
The FDA had been scheduled to act on Spectrum's application for Rolontis by last October, but the inspection of the South Korea plant was delayed until this year by travel restrictions related to the coronavirus pandemic.
The Henderson, Nev., biopharmaceutical company said it is seeking further clarification on the manufacturing issues from the FDA, and that it plans to meet with the agency as soon as possible.
Medical device maker Medtronic said on Friday it would buy Intersect ENT Inc for $936.2 million in cash as it looks to bolster its offerings for ear, nose and throat procedures.
The Dublin, Ireland-headquartered company will buy all outstanding shares of Intersect for $28.25 per share, representing a premium of 15.2% to Intersect's closing price on Thursday.
Medtronic said Intersect's sinus implants would add to its portfolio of devices used by surgeons in the treatment of chronic rhinosinusitis - a common condition characterized by swelling in cavities, or sinuses, in the nose and head. Chronic rhinosinusitis affects more than 35 million adults per year in the United states.
Intersect's PROPEL implant delivers an anti-inflammatory steroid after the sinus surgery while SINUVA implants are used to treat sinus obstruction due to nasal polyps.
"Combining this innovative technology with our established global presence and sales infrastructure will allow us to broaden our capabilities while expanding access to these valuable therapies," said Vince Racano, Medtronic's ENT business president.
The deal values Intersect at $1.1 billion, including debt, and is expected to close toward the end of Medtronic's current fiscal year.
Medtronic expects the deal to be neutral to its adjusted earnings per share in the first 12 months after its close.
Perella Weinberg Partners LP was Medtronic's financial adviser for the deal.
Separately, Intersect said its second-quarter revenue jumped a more than two-fold to $27.3 million from a year earlier, powered by increased demand for the two implants as people resumed elective procedures put off during the pandemic.
Within the next few weeks, the U.S. Food and Drug Administration is expected to recommend a plan forimmunocompromised Americansto get a COVID-19 booster shot, a senior government official familiar with the agency's planning told ABC News on Thursday.
The plan is expected by early September, if not sooner, the government official said.
The timeline was first reported by The Wall Street Journal.
Many immunocompromised Americans have not had high immune responses to the vaccines, leaving them vulnerable to the virus even after getting a shot. Response has been low particularly in transplant recipients, cancer patients or people on medications that suppress their immune response.
Last month, experts on the Centers for Disease Control and Prevention's advisory panel were largely supportive of giving those people a third dose to boost their immunity and called on the FDA to move on the issue.
Booster shots for the general population, which may be made available at some point, may not be part of the FDA's initial priority authorization. The CDC and FDA maintain that there's not enough data to show that immunity has waned enough among vaccinated people to warrant a third shot for everyone -- at this time.
But booster shots for the immunocompromised have become a clear priority.
Asked by ABC News on Thursday during a White House's COVID response briefing when people in that group could expect approval for a third shot, Dr. Anthony Fauci, chief White House medical adviser, said boosters will "be implemented as quickly as possible."
"It is extremely important for us to move to get those individuals their boosters. And we are now working on that, and we'll make that be implemented as quickly as possible. Because for us and for the individuals involved, it is a very high priority," Fauci said.
Fauci also told governors privately on the National Governor's Association call Tuesday that immunocompromised people will be No. 1 in the queue for boosters, and that the FDA was "working on a mechanism" to get additional doses to that group "as soon as we can," according to a readout of the call obtained by ABC News.
He also said he expected the general population to eventually follow.
"I think eventually we all will go that direction," Fauci said, without specifying when.
On Tuesday, the FDA's vaccine chief, Dr. Peter Marks, said that he expected to put out clearer guidance on boosters "by sometime in September."
"I suspect, again, by sometime in September, we'll be able to make some more coherent statement about what the recommendation will be here," Marks said.
Marks said it wouldn't be a blanket road map, but require specific directions for certain groups of people and depend on which shots people originally received.
"We realized that we can't just have a recommendation for one vaccine because it can't just be, 'Well I got vaccine X, what do I do?' We have to have a recommendation for everybody who's been vaccinated," Marks said.
For Phil Canuto, who was left immunocompromised after a kidney transplant 19 years ago, the news of boosters on the horizon left him elated.
"If FDA approval of extra shots for us is imminent, I'm excited," he said in a message to ABC News.
"I know a lot of transplant patients have been trying to get extra shots surreptitiously, lying to pop-up vaccination sites about their previous shots," he said, adding that this news will give patients the chance to make medically informed decisions with their doctors.
The Joint Corp. (NASDAQ: JYNT), a national operator, manager, and franchisor of chiropractic clinics, reported its financial results for the quarter ended
June 30, 2021.
Financial Highlights: Q2 2021 Compared to Q2 2020
Grew revenue 61% to $20.2 million.
Increased system-wide sales1 by 64%, to $87.8 million.
Reported system-wide comp sales2 of 53%.
Posted operating income of $2.0 million, compared to $259,000.
Reported Adjusted EBITDA of $3.8 million, compared to $1.1 million.
Q2 2021 Operating Highlights
Sold 63 franchise licenses, compared to 11 in Q2 2020.
Increased total clinics to 633 at June 30, 2021, 555 franchised and 78 company-owned or managed, up from 592 at March 31, 2021.
Opened 36 new franchised clinics, compared to 12 in Q2 2020.
Opened 5 greenfield clinics, compared to 1 in Q2 2020.
Acquired 8 previously franchised clinics, compared to no activity in Q2 2020.
Raised 2021 Guidance
Due to strong second quarter 2021 revenues, as well as increased franchise openings and greenfield activity, management raised all elements of its 2021 financial guidance.
Revenue is now expected to be between $77.0 million and $79.0 million, up from the May 6, 2021 guidance of between $73.5 million and $77.5 million. The updated mid-point reflects a 33% increase compared to $58.7 million in 2020.
Adjusted EBITDA - which includes the impact of a greater number of greenfields that will be more heavily weighted in the second half of the year - is expected to be between $12.5 million and $13.5 million, up from prior guidance of between $11.0 million and $12.5 million. The updated mid-point reflects a 43% increase compared to $9.1 million in 2020.
The expected number of franchised clinic openings has increased to be between 90 and 110, up from 80 to 100. The updated mid-point reflects a 57% increase compared to 70 in 2020.
The expected number of company-owned or managed clinic increases, through a combination of both greenfields and buybacks, has increased to be between 25 and 35, up from 20 to 30 clinics. The updated mid-point is 7.5 times greater than 4 opened in 2020.
Conference Call The Joint Corp. management will host a conference call at 5 p.m. ET on Thursday, August 5, 2021, to discuss the second quarter 2021 results. Shareholders and interested participants may listen to a live broadcast of the conference call by dialing 765-507-2604 or 844-464-3931 and referencing code 5959205 approximately 15 minutes prior to the start time. The accompanying slide presentation will be in the IR section of the website under Presentations and in Events. A live webcast of the conference call will also be available on the IR section of the company’s website at https://ir.thejoint.com/events. An audio replay will be available two hours after the conclusion of the call through August 13, 2021. The replay can be accessed by dialing 404-537-3406 or 855-859-2056. The passcode for the replay is 5959205.
Suit Details Unlawful Attempts to Solicit Votes on Part of the Activist Group
CytoDyn is Acting to Protect All Shareholders and Prevent Activist Group from Continuing to Violate Federal Securities Laws
CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company, today announced that it has filed a lawsuit in the United States District Court for the District of Delaware against the activist group led by Paul Rosenbaum and Bruce Patterson (the "Rosenbaum/Patterson Group" or the "Activist Group"). The suit seeks to enjoin the Activist Group from misleading shareholders and waging an illegal proxy contest to take over control of the Company’s Board of Directors (the "Board").
As announced on August 2, 2021, CytoDyn has determined that the director nomination notice submitted by the Rosenbaum/Patterson Group was invalid because it failed to comply with the Company’s bylaws in more than 50 instances. The Activist Group has since then stated that it intends to press on with its proxy contest and has continued with its efforts to make misrepresentations to shareholders. The Company has been left with no other option than to sue to enjoin the Rosenbaum/Patterson Group from further violations of the federal securities laws and misleading shareholders.
Gilead Sciences has become aware of tampered and counterfeit versions of its once-daily single tablet HIV treatment regimen Biktarvy® (bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg tablets) and its HIV treatment and prevention medication Descovy® (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets) in circulation within U.S. drug distribution networks. Distributors not authorized by Gilead to sell Gilead-branded medicine have sold these counterfeits to pharmacies where genuine Gilead bottles have been tampered with a counterfeit foil induction seal or label and contain incorrect tablets. Working in communication with the U.S. Food and Drug Administration (FDA), Gilead has alerted potentially impacted pharmacies to investigate the potential for counterfeit or tampered Gilead medication sold by distributors not authorized by Gilead that may be within their recent supply and to remain vigilant to the potential for this to occur in the future. The authenticity and safety of Gilead-branded medicines can only be secure when obtained directly through Gilead’s authorized distributors.
Gilead continues to work closely with the FDA, pharmacies, and legal authorities to remove counterfeit and tampered medication from circulation and to prevent future distribution of these medications.
