Oasmia Gains on Shareholder Pact

Shares of the thinly traded micro-cap biotech OASMIA PHARMACE/ADR OASM 75.61% wereadvancing strongly Friday.

What Happened

Sweden-based Oasmia, which develops new generation human and veterinary oncology drugs, said Friday ahead of the market open that it has reached an agreement with its largest shareholder Arwidsro that would settle all outstanding balances and support a planned capital infusion into Oasmia.

The agreement provides for the fulfillment of a commitment Arwidsro made in January 2018 to provide capital of 75 million Swedish krona ($7.9 million) through the exercise of warrants.

Oasmia will also acquire Arwidsro’s claims OF 60.2 million SEK to MGC for 40.2 million SEK, with the difference added to the former as a positive earnings item, according to Oasmia.

Why It’s Important

These measures will substantially reduce Oasmia’s liabilities and increase its equity and liquidity, the company said.

“It feels good to straighten out some historical question marks and close further parts of our review by fulfilling past agreements. In addition, getting SEK 20 million to reduce our debt burden is very positive,” ChairmanJörgen Olsson said in a statement.

“The most important thing now is to get progress, capital and stability to continue the path towards a commercially successful pharmaceutical company.”

Earlier on Thursday, the company announced the creation of a business advisory board to help with the commercialization of Apealea, its ovarian cancer drug, as well as the evaluation and development of market opportunities for other product candidates.

https://www.benzinga.com/general/biotech/19/07/14034527/why-shares-of-micro-cap-oncology-biotech-oasmia-are-ripping-higher

Senseonics hit as Raymond James cautions on glucose monitor

Senseonics Holdings (NYSEMKT:SENS) has slipped 5.8% after a downgrade to Market Perform by Raymond James, from Outperform.

The firm’s worried about slow uptake on Senseonics’ Eversense implantable continuous glucose monitoring device, which was hamstrung early by slow FDA adoption that delayed its launch. It’s a novel device that has a market, but lack of payer coverage puts Senseonics at a disadvantage, the firm says.

It also argues the Street’s 2020 take looks rich, saying the path to profitability will probably call for more capital at some point.

While sell-side analysts rate it Outperform on average, Seeking Alpha authors are Neutral, and the stock has a Quant Rating of Very Bearish.

https://seekingalpha.com/news/3475902-senseonics-minus-5_8-percent-raymond-james-cautions-cgm-device

Ipsen, Servier Phase 1/2 Pancreatic Cancer Data at ESMO GI Cancer Meet

• Treatment emergent adverse events Grade 3 or higher were reported by 20 of 32 patients from the 50/60 dose pooled patient analysis; no patient reported Grade 3 or higher fatigue or peripheral neuropathy (primary endpoint)
• Approximately three quarters of patients (71.9%) achieved disease control at week 16, while 34% had a response (secondary endpoint)

Ipsen (Euronext: IPN; ADR: IPSEY) and Servier announced today preliminary data from the Phase 1/2 study of the investigational use of liposomal irinotecan (ONIVYDE^®) in combination with 5- fluorouracil/leucovorin (5-FU/LV) and oxaliplatin (OX) in study patients with previously untreated metastatic pancreatic ductal adenocarcinoma cancer (PDAC) at the ESMO 21^st World Congress on Gastrointestinal Cancer in Barcelona, Spain, 3–6 July 2019. The results, which were presented as a short oral presentation, included preliminary safety and efficacy data from an ongoing multicenter, open-label, dose-escalation study, which aims to determine the maximum tolerated dose and the recommended dose to be used in future clinical studies.

https://www.biospace.com/article/releases/ipsen-and-servier-announce-initial-phase-1-2-clinical-data-evaluating-liposomal-irinotecan-onivyde-as-an-investigational-first-line-treatment-for-metastatic-pancreatic-cancer-at-esmo-21st-world-congress-on-gastrointestinal-cancer/

Prescription and over-the-counter eye ointment recalled

Possible sterility issues caused a massive recall of eye ointments, including 91 lots of over-the-counter ointments sold at Walmart, Walgreens and elsewhere.

Another 59 lots of prescription eye ointments made by Altaire Pharmaceuticals for Perrigo Company were included in Wednesday’s announcements. In the company-written, FDA-posted notice of the Perrigo recalls, Altaire said the recalls were, “due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility.”

While the notice said none of the products have tested outside the sterility guidelines, the risk is “administration of a non-sterile product intended to be sterile may result in serious and potentially life-threatening infections or death.”

Of the over-the-counter eye ointments in this recall, 74 lots were sold as Walmart’s store brand, Equate:

Restore Tears Lubricant Eye Drops, Twin Pack; Eye Allergy Relief Drops; Sterile Lubricant Stye Ointment; Comfort Gel Lubricant Eye Gel, Twin Pack; Restore PM Nighttime Lubricant Eye Ointment; Night & Day Restore Tears Lubricant Eye Pack; Equate Support Advanced, Twin Pack; Supprot advanced Lubricating Eye Drops Dose Preservative Free; Support Advanced Lubricant Gel Drops Multi-Dose Preservactive Free; Support Moisture Lubricant Eye Drops; and Support Harmony Lubricant Eye Drops.

If you use any of the above Equate products, click here to see if your ointment was in a recalled lot.

Another six lots of eye ointments were sold as Walgreens store brand:

Lubricant Eye Drops Moisturizing, lot No. 19095; Lubricant Eye Drops Moisturizing Twin Pack, lot No. 19095; Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment, lot No. TCI; Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops, lot Nos. 19105 and 19050; and Lubricant Eye Ointment PF Soothing, lot No. TDB.

And 11 over-the-counter ointments made for Perrigo were sold as Puralube Ophthalmic Ointment. The lot Nos. for those were RJH, SCC, SGA, SGH, SHH, SLL and TAC in the 3.5gm tubes; and RKM, SGA, SIF and SKE in the 1gm tubes.

The 59 lots of prescription ointments are Neomycin and Polymixin B and Bacitracin Zinc Ophthalmic Ointment; NEO-POLY DEX (Neomycin and Polymixin B and Dexamethasone) Ophthalmic Ointment; NEO-POLYCIN HC (Neomycin and Polymixin B and Bacitracin Zinc and Hydrocortisone Acetate) Ophthalmic Ointment; POLYCIN (Polymixin B and Bacitracin Zinc) Ophthalmic Ointment; Bacitracin Ophthalmic Ointment; and Sulfacetamide Sodium Ophthalmic Ointment.

The recalled prescription drug lot list can be found here.

https://www.marketscreener.com/PERRIGO-COMPANY-PLC-15809538/news/Perrigo-Massive-prescription-and-over-the-counter-eye-ointment-recall-over-sterility-concerns-28855299/

Celyad provides update on CAR-T therapies in solid tumors

Celyad (NASDAQ:CYAD) announces that preliminary interim data from the ongoing SHRINK and alloSHRINK Phase 1 trials assessing safety and clinical activity of the NKG2D-based CAR-T therapies CYAD-01 (autologous) and CYAD-101 (allogeneic) for the treatment of metastatic colorectal cancer (mCRC) was presented at the European Society for Medical Oncology (ESMO) 21^st World Congress on Gastrointestinal Cancer (WCGIC).

SHRINK Phase 1 Trial Update: Treatment with CYAD-01 with standard FOLFOX chemotherapy was generally well-tolerated, with no reports of cytokine release syndrome (CRS) grade 2 or higher, related serious adverse events (SAEs) were observed.

A dose–dependent effect on the kinetics of cells with higher levels of cell engraftment was observed.

AlloSHRINK Phase 1 Trial Update: No clinical evidence of Graft-versus-Host Disease (GvHD) have been observed.

Host-versus-Graft (HvG) response against the allogeneic CYAD-101 cells appears to be controlled following the second and third infusions of the allogeneic cell therapy.

Initial observations of disease control, including partial response and stable disease, were observed with CYAD-01 and CYAD-101, in patients who have received prior FOLFOX chemotherapy.

CYAD-101 appears to provide better relative cell engraftment as compared to CYAD-01, at the same dose levels.

Recruitment in alloSHRINK trial is ongoing and preliminary results from the cohort are expected by year-end 2019.

https://seekingalpha.com/news/3475865-celyad-provides-update-car-t-therapies-solid-tumors

Cytori Restructures In Bid To Focus Resources On Lung Cancer Drug

Thinly traded nano-cap biotech Cytori Therapeutics Inc CYTX 0.99%, which has been trading in penny stock territory for about a year now, could see some activity in the wake of a company announcement Friday.

What Happened

Cytori said in an filing with the SEC that CFO Gary Titus notified the company of his intention to resign from his position effective immediately; Cytori said he will continue with the company as an adviser.

The company said its board has approved the appointment of Alan Lins as Titus’ successor as vice president of finance and controller.

The company also said in a filing it has commenced restructuring activities that include a reduction in combined staffing in its California facilities by 46% overall, a reduction in its office space in San Diego; and the streamlining and outsourcing of operations.

Why It’s Important

These actions will extend Cytori’s cash resources, allowing it to focus on its drug pipeline and ATI-1123 in particular, according to the company.

Cytori issued an update Monday on the development of ATI-1123 in the wake of feedback from the FDA that suggested the company could use the 505(b)(2) pathway for regulatory submission.

The regulatory body also said completed non-clinical studies are sufficient to support the initiation of the clinical trial of ATI-1123 in patients with platinum-sensitive small cell lung cancer who have progressed at least 60 days after the initiation of the first-line therapy.

ATI-1123, a substantially redesigned and reformulated new drug based in part on the active pharmaceutical ingredient docetaxel, is in a Phase 1 trial.

Cytori intends to proceed with a follow-on Phase 2 trial.

Cytori said it expects to incur a restructuring charge of about $71,000 primarily in the third quarter of 2019.

https://www.benzinga.com/general/biotech/19/07/14033987/cytori-cfo-resigns-biotech-restructures-in-bid-to-focus-resources-on-lung-cancer-drug

Zai Lab started at Outperform by Macquarie

https://www.benzinga.com/stock/ZLAB/ratings